PEC IMPLANT
FDA 510(k) clearance K961072 · decided 1996-04-19
Clearance details
- K-number
- K961072
- Device name
- PEC 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
- MIC
- Device class
- 2
- Regulation number
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Rand Scientific Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AART PECTORALIS IMPLANT (K021337) | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-03 |
| SILMAX PECTORAL IMPLANT (K002633) | Pillar Surgical, Inc. | 2000-11-21 |
| SEARE BIOMEDICAL PECTORALIS IMPLANT (K982762) | Seare Biomedical Corp. | 1998-09-30 |
| SEARE BIOMEDICAL SILICONE BLOCK (K983043) | Seare Biomedical Corp. | 1998-09-30 |
| POWERFLEX PEC IMPLANT (K973729) | Hanson Medical, Inc. | 1997-12-24 |
| SPECTRUM DISIGNS PECTORAL IMPLANT (K944163) | Spectrum Designs, Inc. | 1994-11-07 |
| PEC IMPLANT (K913768) | Applied Biomaterial Technologies | 1992-02-03 |
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 |