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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Holder, Syringe
510(k) Number K072174
Device Name INSUCOZI INSULIN VIAL COVER
Applicant
41 Industries, LLC
4220 Balsam St.
Wheat Ridge,  CO  80033
Applicant Contact DANIEL LAFAVER
Correspondent
41 Industries, LLC
4220 Balsam St.
Wheat Ridge,  CO  80033
Correspondent Contact DANIEL LAFAVER
Regulation Number890.5050
Classification Product Code
IQG  
Date Received08/06/2007
Decision Date 01/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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