FDA 510(k) Application Details - K982475

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K982475
Device Name Mesh, Surgical, Polymeric
Applicant TISSUE TECHNOLOGIES, INC.
1370 GREEN ST.
SAN FRANCISCO, CA 94109 US
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Contact JESSE KRAMER
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 07/16/1998
Decision Date 09/22/1998
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

FDA Source Information for K982475


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