K953812 is an FDA 510(k) clearance for the GAUZE SPONGE. This device is classified as a Absorber, Saliva, Paper (Class I - General Controls, product code KHR).
Submitted by Remington Medical, Inc. (Atlanta, US). The FDA issued a Cleared decision on October 2, 1995, 61 days after receiving the submission on August 2, 1995.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6050.
| 510(k) Number | K953812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 1995 |
| Decision Date | October 02, 1995 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | KHR - Absorber, Saliva, Paper |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6050 |