The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Fibracol Collagen-alginate Dressing.
Device ID | K925548 |
510k Number | K925548 |
Device Name: | FIBRACOL COLLAGEN-ALGINATE DRESSING |
Classification | Syringe, Piston |
Applicant | JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington, TX 76004 -3130 |
Contact | Wendt |
Correspondent | Wendt JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington, TX 76004 -3130 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-03 |
Decision Date | 1993-07-13 |