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FDA 510(k) Application Details - K211206
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K211206
Device Name
Pump, Infusion
Applicant
Repro-Medical System, Inc., dba Koru Medical Systems
24 Carpenter Road
Chester, NY 10918 US
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Contact
Brian Schiller
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
FRN
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More FDA Info for this Product Code
Date Received
04/22/2021
Decision Date
11/09/2021
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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