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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 K142535
Device Name ConMed Mixing and Delivery Kit
Applicant
Conmed Corporation
11311 Concept Blvd.
Largo,  FL  33773
Applicant Contact Dionne Sanders
Correspondent
Conmed Corporation
11311 Concept Blvd.
Largo,  FL  33773
Correspondent Contact Dionne Sanders
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/09/2014
Decision Date 04/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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