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FDA 510(k) Application Details - K053464
Device Classification Name
Apparatus, Exhaust, Surgical
More FDA Info for this Device
510(K) Number
K053464
Device Name
Apparatus, Exhaust, Surgical
Applicant
CONMED INTEGRATED SYSTEMS, CANADA, ULC
11311 CONCEPT BLVD
LARGO, FL 33773-4908 US
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Contact
MICHAEL T TAGGART
Other 510(k) Applications for this Contact
Regulation Number
878.5070
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Classification Product Code
FYD
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More FDA Info for this Product Code
Date Received
12/13/2005
Decision Date
06/06/2006
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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