K923408 is an FDA 510(k) clearance for the WRAPPEL T. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Standard Textile Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on April 8, 1993, 272 days after receiving the submission on July 10, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K923408 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 1992 |
| Decision Date | April 08, 1993 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |