K943314 is an FDA 510(k) clearance for the ADHESIVE BANDAGES WITH OTC DRUG, a Tape And Bandage, Adhesive (Class I — General Controls, product code KGX), submitted by Johnson & Johnson Consumer Products, Inc. (Skillman, US). The FDA issued a Cleared decision on January 17, 1996, 555 days after receiving the submission on July 11, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5240.
| 510(k) Number | K943314 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 11, 1994 |
| Decision Date | January 17, 1996 |
| Days to Decision | 555 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGX — Tape And Bandage, Adhesive |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.5240 |