K923351 is an FDA 510(k) clearance for the SKIN SUPPORT PREP PAD. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.4730.
| 510(k) Number | K923351 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |