The following data is part of a premarket notification filed by Ovamed Corp. with the FDA for Hysterosys Flexible Hysterocope.
| Device ID | K951946 |
| 510k Number | K951946 |
| Device Name: | HYSTEROSYS FLEXIBLE HYSTEROCOPE |
| Classification | Hysteroscope (and Accessories) |
| Applicant | OVAMED CORP. 760 SAN ALESO AVE. Sunnyvale, CA 94086 |
| Contact | Christine Decaria |
| Correspondent | Christine Decaria OVAMED CORP. 760 SAN ALESO AVE. Sunnyvale, CA 94086 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-26 |
| Decision Date | 1995-11-20 |