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FDA 510(k) Application Details - K161866
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
More FDA Info for this Device
510(K) Number
K161866
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH, MA 07152 US
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Contact
ROBIN FULLER
Other 510(k) Applications for this Contact
Regulation Number
880.5200
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Classification Product Code
FOZ
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More FDA Info for this Product Code
Date Received
07/07/2016
Decision Date
09/08/2016
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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