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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K073533
Device Name SANARUS V2 TREATMENT SYSTEM
Applicant
Sanarus Medical, Inc.
4696 Willow Rd.
Pleasanton,  CA  94588
Applicant Contact LISA HENRY
Correspondent
Sanarus Medical, Inc.
4696 Willow Rd.
Pleasanton,  CA  94588
Correspondent Contact LISA HENRY
Regulation Number878.4350
Classification Product Code
GEH  
Date Received12/17/2007
Decision Date 02/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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