The following data is part of a premarket notification filed by Somnus Medical Technologies, Inc. with the FDA for Somnus Disposable Tissue Coagulating Electrode And Somnus Reusable Connector Cable.
| Device ID | K000720 |
| 510k Number | K000720 |
| Device Name: | SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SOMNUS MEDICAL TECHNOLOGIES, INC. 285 NORTH WOLFE RD. Sunnyvale, CA 94086 |
| Contact | Steven J Ojala |
| Correspondent | Steven J Ojala 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 | 2000-03-03 |
| Decision Date | 2000-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925024670 | K000720 | 000 |
| 00821925027534 | K000720 | 000 |