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FDA 510(k) Application Details - K053296
Device Classification Name
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510(K) Number
K053296
Device Name
MENTOR ARIS SUPRAPUBIC SURGICAL KIT
Applicant
MENTOR CORPORATION
201 MENTOR DRIVE
SANTA BARBARA, CA 93111 US
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Contact
DONNA A CRAWFORD
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Regulation Number
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Classification Product Code
OTN
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Date Received
11/25/2005
Decision Date
12/15/2005
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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