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FDA 510(k) Application Details - K080133
Device Classification Name
Knife, Surgical
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510(K) Number
K080133
Device Name
Knife, Surgical
Applicant
A.M. SURGICAL, INC.
290 EAST MAIN ST. SUITE 200
SMITHTOWN, NY 11787 US
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Contact
VINCENT PASCALE
Other 510(k) Applications for this Contact
Regulation Number
878.4800
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Classification Product Code
EMF
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More FDA Info for this Product Code
Date Received
01/18/2008
Decision Date
03/13/2008
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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