The following data is part of a premarket notification filed by Johnson & Johnson Consumer Products, Inc. with the FDA for Adhesive Bandages With Otc Drug.
| Device ID | K943314 |
| 510k Number | K943314 |
| Device Name: | ADHESIVE BANDAGES WITH OTC DRUG |
| Classification | Tape And Bandage, Adhesive |
| Applicant | JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. GRANDVIEW RD. Skillman, NJ 08558 |
| Contact | Marjorie Mcternan |
| Correspondent | Marjorie Mcternan JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. GRANDVIEW RD. Skillman, NJ 08558 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-11 |
| Decision Date | 1996-01-17 |