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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 K232674
Device Name PainFreeze II
Applicant
Nuance Medical, LLC
5931 Sea Lion Place
Suite 113
Carlsbad,  CA  92010
Applicant Contact Neal Hartman
Correspondent
Nuance Medical, LLC
5931 Sea Lion Place
Suite 113
Carlsbad,  CA  92010
Correspondent Contact Neal Hartman
Classification Product Code
MLY  
Date Received09/01/2023
Decision Date 02/12/2024
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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