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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 K931924
Device Name MARKSMAN ARTERIAL BLOOD GAS SYRINGE
Applicant
Martech Medical Products, Inc.
43223 Business Park Dr.
Temecula,  CA  92590
Applicant Contact STEVEN F MERCEREAU
Correspondent
Martech Medical Products, Inc.
43223 Business Park Dr.
Temecula,  CA  92590
Correspondent Contact STEVEN F MERCEREAU
Regulation Number862.1675
Classification Product Code
JKA  
Date Received04/16/1993
Decision Date 08/03/1993
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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