Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K062896
Device Name V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600
Applicant
Sanarus Medical, Inc.
4696 Willow Rd.
Pleasanton,  CA  94588
Applicant Contact ALAN MARQUARDT
Correspondent
Sanarus Medical, Inc.
4696 Willow Rd.
Pleasanton,  CA  94588
Correspondent Contact ALAN MARQUARDT
Regulation Number878.4350
Classification Product Code
GEH  
Date Received09/27/2006
Decision Date 01/03/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-