K953914 is an FDA 510(k) clearance for the KENTEX. This device is classified as a Gauze/sponge, Internal.
Submitted by Kentron Health Care, Inc. (Hollywood, US). The FDA issued a Cleared decision on November 6, 1995, 77 days after receiving the submission on August 21, 1995.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K953914 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 21, 1995 |
| Decision Date | November 06, 1995 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | EFQ — Gauze/sponge, Internal |
| Device Class | — |