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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vapocoolant Device
510(k) Number K162218
Device Name Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102
Applicant
Nuance Medical, LLC
5931 Sea Lion Place, Suite 113
Carlsbad,  CA  92008
Applicant Contact MARC LIEBERMAN
Correspondent
Nuance Medical, LLC
5931 Sea Lion Place, Suite 113
Carlsbad,  CA  92008
Correspondent Contact MARC LIEBERMAN
Classification Product Code
MLY  
Date Received08/08/2016
Decision Date 11/22/2016
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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