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FDA 510(k) Application Details - K113673
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K113673
Device Name
Syringe, Piston
Applicant
MEDICALCHAIN INTERNARTIONAL CORPORATION
1808 SEABREEZE COURT
THOUSAND OAKS, CA 91320 US
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Contact
ROBIN HWANG
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
FMF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/13/2011
Decision Date
08/03/2012
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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