The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Integra Flowable Wound Matrix, Model Fwd301.
| Device ID | K072113 |
| 510k Number | K072113 |
| Device Name: | INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301 |
| Classification | Dressing, Wound, Collagen |
| Applicant | INTEGRA LIFESCIENCES CORP. 311C ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Diana M Bordon |
| Correspondent | Diana M Bordon INTEGRA LIFESCIENCES CORP. 311C ENTERPRISE DRIVE 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 | 2007-08-01 |
| Decision Date | 2007-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M269FWD3011 | K072113 | 000 |