Submission Details
| 510(k) Number | K953812 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
GAUZE SPONGE
Oct 1995
Decision
61d
Days
Class 1
Risk
About This 510(k) Submission
K953812 is an FDA 510(k) clearance for the GAUZE SPONGE, 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 review panel. Regulated under 21 CFR 872.6050.
Device Classification
| Product Code | KHR — Absorber, Saliva, Paper |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.6050 |
Manufacturer
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