The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Fibrcol Plus Collagen Wound Dressing With Alginate.
| Device ID | K982597 |
| 510k Number | K982597 |
| Device Name: | FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE |
| Classification | Dressing, Wound, Collagen |
| Applicant | JOHNSON & JOHNSON MEDICAL, INC. 2500 ARBROOK BLVD. P.O. BOX 90130 Arlington, TX 76004 -0130 |
| Contact | Terry J Dagnon |
| Correspondent | Terry J Dagnon JOHNSON & JOHNSON MEDICAL, INC. 2500 ARBROOK BLVD. P.O. BOX 90130 Arlington, TX 76004 -0130 |
| 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 | 1998-07-24 |
| Decision Date | 1998-08-20 |
| Summary: | summary |