K923351 is an FDA 510(k) clearance for the SKIN SUPPORT PREP PAD, a Solvent, Adhesive Tape (Class I — General Controls, product code KOX), submitted by Coloplast Corp. (Marietta, US). The FDA issued a Cleared decision on September 14, 1992, 68 days after receiving the submission on July 8, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4730.
| 510(k) Number | K923351 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 08, 1992 |
| Decision Date | September 14, 1992 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KOX — Solvent, Adhesive Tape |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4730 |