The following data is part of a premarket notification filed by Vnus Medical Technologies, Inc. with the FDA for Vnus Closure System.
| Device ID | K974521 |
| 510k Number | K974521 |
| Device Name: | VNUS CLOSURE SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VNUS MEDICAL TECHNOLOGIES, INC. 238 EAST CARIBBEAN DR. Sunnyvale, CA 94089 |
| Contact | Tom Holdych |
| Correspondent | Tom Holdych VNUS MEDICAL TECHNOLOGIES, INC. 238 EAST CARIBBEAN 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 | 1997-12-02 |
| Decision Date | 1998-02-20 |
| Summary: | summary |