K983368 is an FDA 510(k) clearance for the CARE BAND ANTIBACTERIAL BANDAGES, a Tape And Bandage, Adhesive (Class I — General Controls, product code KGX), submitted by Aso Corp. (Sarasota, US). The FDA issued a Cleared decision on February 17, 1999, 146 days after receiving the submission on September 24, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5240.
| 510(k) Number | K983368 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 24, 1998 |
| Decision Date | February 17, 1999 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KGX — Tape And Bandage, Adhesive |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.5240 |