The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Modified Labeling For Bioclusive* Trans Film Dress.
| Device ID | K901853 |
| 510k Number | K901853 |
| Device Name: | MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS |
| Classification | Dressing, Wound, Drug |
| Applicant | JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 2500 ARBROOK BLVD. Arlington, TX 76004 -3130 |
| Contact | John E Friend |
| Correspondent | John E Friend JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 2500 ARBROOK BLVD. Arlington, TX 76004 -3130 |
| 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 | 1990-04-24 |
| Decision Date | 1991-01-28 |