BILAYER MATRIX WOUND DRESSING
FDA 510(k) clearance K021792 · decided 2002-08-14
Clearance details
- K-number
- K021792
- Device name
- BILAYER MATRIX WOUND DRESSING
- Applicant
- Integra Lifesciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-31
- Decision date
- 2002-08-14
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- KGN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Planisboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm x 25 cm); Non-pyrogenic, Do not recall (Z-1174-2009) | Integra LifeSciences Corp. | 2009-04-07 |