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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K910970
Device Name MARKSMAN ARTERIAL BLOOD GAS SYRINGE
Applicant
Martech Medical Products, Inc.
7555 Jurupa Ave.
Suite E
Riverside,  CA  92504
Applicant Contact MICHAEL D MARTELL
Correspondent
Martech Medical Products, Inc.
7555 Jurupa Ave.
Suite E
Riverside,  CA  92504
Correspondent Contact MICHAEL D MARTELL
Regulation Number862.1675
Classification Product Code
JKA  
Date Received03/07/1991
Decision Date 10/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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