The following data is part of a premarket notification filed by Gynecare Innovation Center with the FDA for Soprano Cryo-therapy System.
| Device ID | K980393 |
| 510k Number | K980393 |
| Device Name: | SOPRANO CRYO-THERAPY SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYNECARE INNOVATION CENTER 1221 INNSBRUCK DR. Sunnyvale, CA 94089 |
| Contact | Jean Ladouceur |
| Correspondent | Jean Ladouceur GYNECARE INNOVATION CENTER 1221 INNSBRUCK DR. Sunnyvale, CA 94089 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-02 |
| Decision Date | 1998-05-01 |
| Summary: | summary |