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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K812560
Device Name MDM ARTERIAL BLOOD GAS SYRINGE
Applicant
Martell Medical Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Martell Medical Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/08/1981
Decision Date 10/09/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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