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FDA 510(k) Application Details - K110794
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
More FDA Info for this Device
510(K) Number
K110794
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
AMECO MEDICAL INDUSTRIES
79 BROOKLINE ROAD
MASON, NH 03048 US
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Contact
Ray Kelly
Other 510(k) Applications for this Contact
Regulation Number
880.5200
More FDA Info for this Regulation Number
Classification Product Code
FOZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/22/2011
Decision Date
12/21/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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