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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 K130995
Device Name NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY
Applicant
NUANCE MEDICAL, LLC
300 CARLSBAD VILLAGE DRIVE, SUITE 108
CARLSBAD,  CA  92008
Applicant Contact MARC S LIEBERMAN
Correspondent
NUANCE MEDICAL, LLC
300 CARLSBAD VILLAGE DRIVE, SUITE 108
CARLSBAD,  CA  92008
Correspondent Contact MARC S LIEBERMAN
Regulation Number878.4350
Classification Product Code
GEH  
Date Received04/10/2013
Decision Date 06/14/2013
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
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