The following data is part of a premarket notification filed by Unimar, Inc. with the FDA for Hsg Tray.
| Device ID | K920803 |
| 510k Number | K920803 |
| Device Name: | HSG TRAY |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | UNIMAR, INC. 475 DANBURY RD. Wilton, CT 06897 |
| Contact | Edward C Vollmer |
| Correspondent | Edward C Vollmer UNIMAR, INC. 475 DANBURY RD. Wilton, CT 06897 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-21 |
| Decision Date | 1992-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937003264 | K920803 | 000 |