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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Collection, Capillary Blood
510(k) Number K843608
Device Name CAPILLARY BLOOD COLLECTION TUBE
Applicant
Medical Technomics, Ltd.
274 Cottage Hill Ave.
Elmhurst,  IL  60126
Applicant Contact DENNIS A ALDRED
Correspondent
Medical Technomics, Ltd.
274 Cottage Hill Ave.
Elmhurst,  IL  60126
Correspondent Contact DENNIS A ALDRED
Regulation Number864.6150
Classification Product Code
GIO  
Date Received09/13/1984
Decision Date 11/30/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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