FDA 510(k) Application Details - K031767

Device Classification Name

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510(K) Number K031767
Device Name MENTOR OBTAPE TRANS-OBTURATOR TAPE
Applicant MENTOR CORP.
201 MENTOR DR.
SANTA BARBARA, CA 93111 US
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Contact DONNA CRAWFORD
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Regulation Number

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Classification Product Code OTN
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Date Received 06/09/2003
Decision Date 07/17/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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