HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
FDA 510(k) clearance K961511 · decided 1996-06-28
Clearance details
- K-number
- K961511
- Device name
- HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
- Applicant
- Lifecore Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-19
- Decision date
- 1996-06-28
- Days to decision
- 70 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
- Chaska, MN, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| AART MALAR IMPLANT (K021419) | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-02 |
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| 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 |
|---|---|---|
| GYNECARE INTERGEL ADHESION PREVENTION SOLUTION (P990015/S002) | Lifecore Biomedical, Inc. | 2003-03-18 |
| GYNECARE INTERGEL ADHESION PREVENTION SOLUTION (P990015/S001) | Lifecore Biomedical, Inc. | 2002-07-09 |
| INTERGEL ADHESION PREVENTION SOLUTION (P990015) | Lifecore Biomedical, Inc. | 2001-11-16 |