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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 K172028
Device Name Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)
Applicant
Gebauer Company
4444 East 153rd Street
Cleveland,  OH  44128
Applicant Contact Brittney Schmies
Correspondent
Gebauer Company
4444 East 153rd Street
Cleveland,  OH  44128
Correspondent Contact Brittney Schmies
Classification Product Code
MLY  
Date Received07/05/2017
Decision Date 10/27/2017
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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