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FDA 510(k) Application Details - K080341
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K080341
Device Name
Drape, Surgical
Applicant
VORTEK SURGICAL, LLC
1426 W. 29TH ST. SUITE 300
INDIANAPOLIS, IN 46208 US
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Contact
THOMAS SZYMCZAK
Other 510(k) Applications for this Contact
Regulation Number
878.4370
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Classification Product Code
KKX
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More FDA Info for this Product Code
Date Received
02/08/2008
Decision Date
07/21/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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