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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 K061510
Device Name SANARUS VISICA TREATMENT SYSTEM
Applicant
SANARUS MEDICAL, INC.
4696 WILLOW RD.
PLEASANTON,  CA  94588
Applicant Contact TRENA DEPEL
Correspondent
SANARUS MEDICAL, INC.
4696 WILLOW RD.
PLEASANTON,  CA  94588
Correspondent Contact TRENA DEPEL
Regulation Number878.4350
Classification Product Code
GEH  
Date Received06/01/2006
Decision Date 07/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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