FDA 510(k) Application Details - K973082

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K973082
Device Name Mesh, Surgical, Polymeric
Applicant SPECIALTY SURGICAL PRODUCTS, INC.
302 NORTH FIRST ST.
HAMILTON, MT 59840 US
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Contact T. JAN VARNER
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 08/18/1997
Decision Date 11/04/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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