The following data is part of a premarket notification filed by Omni Intl., Inc. with the FDA for Omnimed Surgical Gown.
| Device ID | K851938 |
| 510k Number | K851938 |
| Device Name: | OMNIMED SURGICAL GOWN |
| Classification | Gown, Surgical |
| Applicant | OMNI INTL., INC. 870 RESEARCH DR. UNIT 5 Palm Springs, CA 92263 |
| Contact | Raman Kadevari |
| Correspondent | Raman Kadevari OMNI INTL., INC. 870 RESEARCH DR. UNIT 5 Palm Springs, CA 92263 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-03 |
| Decision Date | 1985-06-28 |