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FDA 510(k) Application Details - K122404
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K122404
Device Name
Set, Administration, Intravascular
Applicant
REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS
24 CARPENTER RD
CHESTER, NY 10918 US
Other 510(k) Applications for this Company
Contact
ANDREW I SEALFON
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/07/2012
Decision Date
05/06/2013
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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