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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K102178
Device Name EASY TOUCH
Applicant
Mhc Medical Products
8870 Ravello Ct.
Naples,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
Mhc Medical Products
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/03/2010
Decision Date 09/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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