The following data is part of a premarket notification filed by Unimar, Inc. with the FDA for Hui Mini-flex.
| Device ID | K895659 |
| 510k Number | K895659 |
| Device Name: | HUI MINI-FLEX |
| Classification | Insufflator, Hysteroscopic |
| Applicant | UNIMAR, INC. 475 DANBURY RD. Wilton, CT 06897 |
| Contact | Anthony Hemming |
| Correspondent | Anthony Hemming UNIMAR, INC. 475 DANBURY RD. Wilton, CT 06897 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-20 |
| Decision Date | 1989-12-19 |