The following data is part of a premarket notification filed by Gynecare Innovation Center with the FDA for Femrx Focused Monopolar (fmp) Opera Star System.
| Device ID | K971305 |
| 510k Number | K971305 |
| Device Name: | FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM |
| Classification | Hysteroscope (and Accessories) |
| Applicant | GYNECARE INNOVATION CENTER 1221 INNSBRUCK DR. Sunnyvale, CA 94089 |
| Contact | George M Savage |
| Correspondent | George M Savage GYNECARE INNOVATION CENTER 1221 INNSBRUCK DR. Sunnyvale, CA 94089 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-08 |
| Decision Date | 1997-08-11 |
| Summary: | summary |