The following data is part of a premarket notification filed by Frigitronics, Inc. with the FDA for Hysteromat Hysteroflator Hysteroscopic Insufflator.
| Device ID | K905495 |
| 510k Number | K905495 |
| Device Name: | HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR |
| Classification | Insufflator, Hysteroscopic |
| Applicant | FRIGITRONICS, INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose FRIGITRONICS, INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-07 |
| Decision Date | 1991-04-29 |