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FDA 510(k) Application Details - K031767
Device Classification Name
More FDA Info for this Device
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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More FDA Info for this Product Code
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
FDA Source Information for K031767
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