The following data is part of a premarket notification filed by Johnson & Johnson Medical, Ltd. with the FDA for Collagen-orc Antimicrobial Matrix.
| Device ID | K033523 |
| 510k Number | K033523 |
| Device Name: | COLLAGEN-ORC ANTIMICROBIAL MATRIX |
| Classification | Dressing, Wound, Drug |
| Applicant | JOHNSON & JOHNSON MEDICAL, LTD. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 |
| Contact | John D Paulson |
| Correspondent | John D Paulson JOHNSON & JOHNSON MEDICAL, LTD. ROUTE 22 WEST P.O. BOX 151 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 | Yes |
| Date Received | 2003-11-07 |
| Decision Date | 2004-10-21 |
| Summary: | summary |