The following data is part of a premarket notification filed by Unimar, Inc. with the FDA for Sterile/disposable Hsg Tray.
| Device ID | K810291 |
| 510k Number | K810291 |
| Device Name: | STERILE/DISPOSABLE HSG TRAY |
| Classification | Drape, Urological, Disposable |
| Applicant | UNIMAR, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EYY |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-03 |
| Decision Date | 1981-03-18 |