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FDA 510(k) Application Details - K103736
Device Classification Name
Syringe, Piston
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
FMF
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More FDA Info for this Product Code
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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