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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 K033720
Device Name ARI COLD SPRAY
Applicant
Ari
1733 Canton Ln.
Marietta,  GA  30062
Applicant Contact RON ARKIN
Correspondent
Ari
1733 Canton Ln.
Marietta,  GA  30062
Correspondent Contact RON ARKIN
Classification Product Code
MLY  
Date Received11/26/2003
Decision Date 06/10/2005
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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