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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 K873647
Device Name VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE
Applicant
VENTREX LABORATORIES, INC.
217 READ ST.
P.O. BOX 9731
PORTLAND,  ME  04103
Applicant Contact JAMES W CHAMPLIN
Correspondent
VENTREX LABORATORIES, INC.
217 READ ST.
P.O. BOX 9731
PORTLAND,  ME  04103
Correspondent Contact JAMES W CHAMPLIN
Regulation Number864.6150
Classification Product Code
GIO  
Date Received09/09/1987
Decision Date 10/20/1987
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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