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FDA 510(k) Application Details - K023173
Device Classification Name
Instrument, Manual, Surgical, General Use
More FDA Info for this Device
510(K) Number
K023173
Device Name
Instrument, Manual, Surgical, General Use
Applicant
ANDREWS SURGICAL INNOVATIONS, LTD.
16 GROVE LAWN
MALAHIDE
CO. DUBLIN IE
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Contact
EMMET ANDREWS
Other 510(k) Applications for this Contact
Regulation Number
878.4800
More FDA Info for this Regulation Number
Classification Product Code
MDM
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More FDA Info for this Product Code
Date Received
09/23/2002
Decision Date
12/18/2002
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
FDA Source Information for K023173
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