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FDA 510(k) Application Details - K131571
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K131571
Device Name
Drape, Surgical
Applicant
ADVANCED VASCULAR DYNAMICS
4252 SE International Way Ste F
Milwaukie, OR 97222 US
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Contact
MATTHEW SEMLER
Other 510(k) Applications for this Contact
Regulation Number
878.4370
More FDA Info for this Regulation Number
Classification Product Code
KKX
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More FDA Info for this Product Code
Date Received
05/30/2013
Decision Date
01/31/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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