The following data is part of a premarket notification filed by United Medical Ent., Inc. with the FDA for Surgical Mask (non-sterile).
| Device ID | K955513 |
| 510k Number | K955513 |
| Device Name: | SURGICAL MASK (NON-STERILE) |
| Classification | Mask, Surgical |
| Applicant | UNITED MEDICAL ENT., INC. 5003 WRIGHTSBORO RD. Grovetown, GA 30813 |
| Contact | Herschel Pitts |
| Correspondent | Herschel Pitts UNITED MEDICAL ENT., INC. 5003 WRIGHTSBORO RD. Grovetown, GA 30813 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-04 |
| Decision Date | 1996-04-22 |