The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Wound Matrix (thin).
| Device ID | K113104 |
| 510k Number | K113104 |
| Device Name: | INTEGRA WOUND MATRIX (THIN) |
| Classification | Dressing, Wound, Collagen |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Stephen H Beier |
| Correspondent | Stephen H Beier INTEGRA LIFESCIENCES CORPORATION 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 | 2011-10-20 |
| Decision Date | 2012-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M26954101T1 | K113104 | 000 |
| M26954051T1 | K113104 | 000 |
| M26958101T1 | K113104 | 000 |
| M26952021T1 | K113104 | 000 |