MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL
FDA 510(k) clearance K952677 · decided 1995-08-21
Clearance details
- K-number
- K952677
- Device name
- MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL
- Applicant
- Porex Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-06-12
- Decision date
- 1995-08-21
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- FWP
- Device class
- 2
- Regulation number
- 878.3550
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- College Park, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet recall (Z-1091-2015) | Stryker Craniomaxillofacial Division | 2015-02-11 |
| MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-for recall (Z-1092-2015) | Stryker Craniomaxillofacial Division | 2015-02-11 |