FDA 510(k) Application Details - K103736

Device Classification Name Syringe, Piston

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510(K) Number K103736
Device Name Syringe, Piston
Applicant DMC MEDICAL LTD.
944 NORTH MAIN STREET
BOUNTIFUL, UT 84010 US
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Contact TRACY BEST
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 12/22/2010
Decision Date 06/10/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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