FDA 510(k) Application Details - K980483

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K980483
Device Name Mesh, Surgical, Polymeric
Applicant MENTOR CORP.
5425 HOLLISTER AVE.
SANTA BARBARA, CA 93111 US
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Contact DONNA A CRAWFORD
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 02/09/1998
Decision Date 04/30/1998
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



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