FDA 510(k) Application Details - K023680

Device Classification Name Cement Obturator

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510(K) Number K023680
Device Name Cement Obturator
Applicant SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS, TN 38116 US
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Contact DAVID HENLEY
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Regulation Number 878.3300

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Classification Product Code LZN
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Date Received 11/01/2002
Decision Date 11/19/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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