The following data is part of a premarket notification filed by Vnus Medical Technologies, Inc. with the FDA for Vnus Vessel And Tissue Coagulation System.
Device ID | K033547 |
510k Number | K033547 |
Device Name: | VNUS VESSEL AND TISSUE COAGULATION SYSTEM |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | VNUS MEDICAL TECHNOLOGIES, INC. 750 CHESAPEAKE DR. Redwood City, CA 94063 |
Contact | Sam Nanavati |
Correspondent | Sam Nanavati VNUS MEDICAL TECHNOLOGIES, INC. 750 CHESAPEAKE DR. Redwood City, CA 94063 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-11-12 |
Decision Date | 2004-01-07 |
Summary: | summary |