The following data is part of a premarket notification filed by Alphamedix, Inc. with the FDA for Disposable Surgical Garments.
| Device ID | K820363 |
| 510k Number | K820363 |
| Device Name: | DISPOSABLE SURGICAL GARMENTS |
| Classification | Gown, Surgical |
| Applicant | ALPHAMEDIX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-09 |
| Decision Date | 1982-03-08 |