FDA 510(k) Application Details - K020480

Device Classification Name Retention Device, Suture

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510(K) Number K020480
Device Name Retention Device, Suture
Applicant SMITH & NEPHEW, INC.
130 FORBES BLVD.
MANSFIELD, MA 02048 US
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Contact WILLIAM MCCALLUM
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Regulation Number 878.4930

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Classification Product Code KGS
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Date Received 02/13/2002
Decision Date 03/12/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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