The following data is part of a premarket notification filed by Circon Acmi with the FDA for Gyn-1500 Hysteroscopic Inufflator.
| Device ID | K905706 |
| 510k Number | K905706 |
| Device Name: | GYN-1500 HYSTEROSCOPIC INUFFLATOR |
| Classification | Insufflator, Hysteroscopic |
| Applicant | CIRCON ACMI 300 STILLWATER AVE. P.O. BOX 1971 Stamford, CT 06904 -1971 |
| Contact | Ervin F Taylor |
| Correspondent | Ervin F Taylor CIRCON ACMI 300 STILLWATER AVE. P.O. BOX 1971 Stamford, CT 06904 -1971 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-24 |
| Decision Date | 1991-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925002630 | K905706 | 000 |