The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Nu-brede Packing And Debridement Sponge.
| Device ID | K921983 |
| 510k Number | K921983 |
| Device Name: | NU-BREDE PACKING AND DEBRIDEMENT SPONGE |
| Classification | Gauze/sponge, Internal |
| 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 | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-28 |
| Decision Date | 1992-09-18 |