FDA 510(k) Application Details - K023173

Device Classification Name Instrument, Manual, Surgical, General Use

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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
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Regulation Number 878.4800

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Classification Product Code MDM
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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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