The following data is part of a premarket notification filed by Somnus Medical Technologies, Inc. with the FDA for Somnoplasty System.
| Device ID | K971450 |
| 510k Number | K971450 |
| Device Name: | SOMNOPLASTY SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SOMNUS MEDICAL TECHNOLOGIES, INC. 285 NORTH WOLFE RD. Sunnyvale, CA 94086 |
| Contact | Eve Conner |
| Correspondent | Eve Conner SOMNUS MEDICAL TECHNOLOGIES, INC. 285 NORTH WOLFE RD. Sunnyvale, CA 94086 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-21 |
| Decision Date | 1997-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925010833 | K971450 | 000 |