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FDA 510(k) Application Details - K150407
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
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510(K) Number
K150407
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH, MA 01752 US
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Contact
Brandon M Brackett
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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
02/18/2015
Decision Date
05/15/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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