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FDA 510(k) Application Details - K954940
Device Classification Name
Light, Surgical, Accessories
More FDA Info for this Device
510(K) Number
K954940
Device Name
Light, Surgical, Accessories
Applicant
MDT BIOLOGIC CO.
1777 EAST HENRIETTA RD.
P.O. BOX 23077
ROCHESTER, NY 14692 US
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Contact
CHARLES O HANCOCK
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Regulation Number
878.4580
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Classification Product Code
FTA
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More FDA Info for this Product Code
Date Received
10/30/1995
Decision Date
01/17/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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