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FDA 510(k) Application Details - K032400
Device Classification Name
Apparatus, Exhaust, Surgical
More FDA Info for this Device
510(K) Number
K032400
Device Name
Apparatus, Exhaust, Surgical
Applicant
VISION PRO, L.L.C.
1050 CONNECTICUT AVENUE, NW
WASHINGTON, DC 20036 US
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Contact
WAYNE H MATELSKI
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
08/04/2003
Decision Date
05/07/2004
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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