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FDA 510(k) Application Details - K102969
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K102969
Device Name
Syringe, Piston
Applicant
INTERNATIONAL MEDSURG CONNECTION
935 N PLUM GROVE RD, STE F
SCHAUMBURG, IL 60173 US
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Contact
PETER KIM
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
10/06/2010
Decision Date
12/20/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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