The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Integra Meshed Bilayer Wound Matrix.
| Device ID | K081635 |
| 510k Number | K081635 |
| Device Name: | INTEGRA MESHED BILAYER WOUND MATRIX |
| Classification | Dressing, Wound, Drug |
| 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 | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-11 |
| Decision Date | 2008-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M269MWM81011 | K081635 | 000 |
| M269MWM41011 | K081635 | 000 |
| M269MWM40511 | K081635 | 000 |
| M269MWM20211 | K081635 | 000 |