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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 K022314
Device Name SANARUS VISICA TREATMENT SYSTEM
Applicant
SANARUS MEDICAL, INC.
5880 WEST LAS POSITAS,SUITE 52
PLEASANTON,  CA  94588
Applicant Contact SETH STABINSKY
Correspondent
SANARUS MEDICAL, INC.
5880 WEST LAS POSITAS,SUITE 52
PLEASANTON,  CA  94588
Correspondent Contact SETH STABINSKY
Regulation Number878.4350
Classification Product Code
GEH  
Date Received07/17/2002
Decision Date 10/15/2002
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
Recalls CDRH Recalls
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