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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arterial Blood Sampling Kit
510(k) Number K944941
Device Name PISTON SYRINGE
Applicant
Martell Medical Products, Inc.
26637 Pierce Circle
Murrieta,  CA  92562 -7024
Applicant Contact MICHAEL D MARTELL
Correspondent
Martell Medical Products, Inc.
26637 Pierce Circle
Murrieta,  CA  92562 -7024
Correspondent Contact MICHAEL D MARTELL
Regulation Number868.1100
Classification Product Code
CBT  
Date Received10/07/1994
Decision Date 12/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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