MEDIAL MALAR IMPLANT
FDA 510(k) clearance K961080 · decided 1996-04-19
Clearance details
- K-number
- K961080
- Device name
- MEDIAL MALAR IMPLANT
- Applicant
- Rand Scientific Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-03-18
- Decision date
- 1996-04-19
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- LZK
- Device class
- 2
- Regulation number
- 878.3550
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AART MALAR IMPLANT (K021419) | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-02 |
| IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) (K002886) | Implantech Associates, Inc. | 2000-11-24 |
| PILLAR MALAR IMPLANT (K992240) | Pillar Surgical, Inc. | 1999-11-22 |
| SURGIFORM ANATOMICAL MALAR (K983756) | Surgical Technology Laboratories, Inc. | 1998-11-20 |
| SEARE BIOMEDICAL MALAR IMPLANTS (K982763) | Seare Biomedical Corp. | 1998-09-30 |
| SILIMED MALAR IMPLANT (K981835) | Silimed, LLC | 1998-07-09 |
| SPECTRUM DESIGNS PROFILE MALAR IMPLANT (K980139) | Spectrum Designs, Inc. | 1998-03-03 |
| SPECTRUM DESIGNS PROJECTION MALAR IMPLANT (K980141) | Spectrum Designs, Inc. | 1998-03-03 |
| SPECTRUM DESIGNS MEDIAL MALAR IMPLANT (K980140) | Spectrum Designs, Inc. | 1998-03-03 |
| IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT (K973502) | Implantech Associates, Inc. | 1997-11-07 |
| DURALASTIC ANATOMICAL MALAR IMPLANT (K973574) | Hanson Medical, Inc. | 1997-10-24 |
| DURALASTIC ANATOMICAL MALAR IMPLANTS (K971479) | Allied Biomedical Corp. | 1997-07-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES (P890044/S027) | Rand Scientific Corp. | 1994-01-26 |
| TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES (P890044/S026) | Rand Scientific Corp. | 1993-05-27 |
| TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES (P890044/S025) | Rand Scientific Corp. | 1993-02-09 |
| ADD RGP LENS FINISHING LABORATORIES. (P890044/S024) | Rand Scientific Corp. | 1993-02-05 |
| ADD RGP LENS FINISHING LABORATORIES. (P890044/S023) | Rand Scientific Corp. | 1992-09-30 |
| ADD RGP LENS FINISHING LABORATORIES. (P890044/S022) | Rand Scientific Corp. | 1992-09-01 |
| ADD RGP LENS FINISHING LABORATORIES. (P890044/S021) | Rand Scientific Corp. | 1992-06-26 |
| ADD RGP LENS FINISHING LABORATORIES. (P890044/S020) | Rand Scientific Corp. | 1992-04-14 |