The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Bilayer Matrix Wound Dressing.
| Device ID | K021792 |
| 510k Number | K021792 |
| Device Name: | BILAYER MATRIX WOUND DRESSING |
| Classification | Dressing, Wound, Collagen |
| Applicant | INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Diana M Bordon |
| Correspondent | Diana M Bordon INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-31 |
| Decision Date | 2002-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M269BMW8101 | K021792 | 000 |
| M269BMW4101 | K021792 | 000 |
| 10381780032243 | K021792 | 000 |
| M269BMW41011 | K021792 | 000 |
| M269BMW40511 | K021792 | 000 |
| M269BMW20211 | K021792 | 000 |
| M269BMW4051 | K021792 | 000 |
| M269BMW81011 | K021792 | 000 |