The following data is part of a premarket notification filed by Johnson & Johnson Consumer Products, Inc. with the FDA for Band-aid(tm) Brand Adhesive Bandage.
| Device ID | K940536 |
| 510k Number | K940536 |
| Device Name: | BAND-AID(TM) BRAND ADHESIVE BANDAGE |
| Classification | Tape And Bandage, Adhesive |
| Applicant | JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. U.S. ROUTE #1 North Brunswick, NJ 08903 |
| Contact | Majorie Mcternan |
| Correspondent | Majorie Mcternan JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. U.S. ROUTE #1 North Brunswick, NJ 08903 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-07 |
| Decision Date | 1994-10-03 |