The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Avagen Wound Dressing.
| Device ID | K022127 |
| 510k Number | K022127 |
| Device Name: | AVAGEN WOUND DRESSING |
| Classification | Dressing, Wound, Collagen |
| Applicant | INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Judith E O'grady |
| Correspondent | Judith E O'grady 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 | 2002-07-01 |
| Decision Date | 2002-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M269581051 | K022127 | 000 |
| M269541051 | K022127 | 000 |
| M269540551 | K022127 | 000 |
| M269520251 | K022127 | 000 |
| M269581011 | K022127 | 000 |
| M269541011 | K022127 | 000 |
| M269540511 | K022127 | 000 |
| M269520211 | K022127 | 000 |