The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Biopatch Antimicrobial Dressing.
| Device ID | K003229 |
| 510k Number | K003229 |
| Device Name: | BIOPATCH ANTIMICROBIAL DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | INTEGRA LIFESCIENCES CORP. ROUTE 22 Somerville, NJ 08876 |
| Contact | William Goeller |
| Correspondent | William Goeller INTEGRA LIFESCIENCES CORP. ROUTE 22 Somerville, NJ 08876 |
| 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 | 2000-10-10 |
| Decision Date | 2001-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705031132911 | K003229 | 000 |
| 30705031001118 | K003229 | 000 |
| 30705031001125 | K003229 | 000 |
| 30705031004331 | K003229 | 000 |
| 30705031004348 | K003229 | 000 |
| 30705031004355 | K003229 | 000 |
| 30705031005239 | K003229 | 000 |
| 30705031005246 | K003229 | 000 |
| 30705031005253 | K003229 | 000 |
| 30705031132898 | K003229 | 000 |
| 30705031132904 | K003229 | 000 |
| 30705031001101 | K003229 | 000 |