FDA 510(k) Application Details - K032400

Device Classification Name Apparatus, Exhaust, Surgical

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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
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Regulation Number 878.5070

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Classification Product Code FYD
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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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