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FDA 510(k) Application Details - K955810
Device Classification Name
Clamp, Penile
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510(K) Number
K955810
Device Name
Clamp, Penile
Applicant
LABORIE MEDICAL TECHNOLOGIES, LTD.
6415 NORTHWEST DR.
UNIT 11
MISSISSAUGA (ONTARIO) L4V 1X1 CA
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FRED BUFFA
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Regulation Number
876.5160
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Classification Product Code
FHA
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Date Received
12/26/1995
Decision Date
01/24/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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