The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Gauze Sponge.
| Device ID | K953812 |
| 510k Number | K953812 |
| Device Name: | GAUZE SPONGE |
| Classification | Absorber, Saliva, Paper |
| Applicant | REMINGTON MEDICAL, INC. 8601 DUNWOODY PL., SUITE 510 Atlanta, GA 30350 |
| Contact | Don Rosvold |
| Correspondent | Don Rosvold REMINGTON MEDICAL, INC. 8601 DUNWOODY PL., SUITE 510 Atlanta, GA 30350 |
| Product Code | KHR |
| CFR Regulation Number | 872.6050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-02 |
| Decision Date | 1995-10-02 |