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FDA 510(k) Application Details - K960508
Device Classification Name
Perineometer
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510(K) Number
K960508
Device Name
Perineometer
Applicant
THE PROMETHEUS GROUP
80 BOW ST.
PORTSMOUTH, NH 03801 US
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Contact
RICHARD W POORE
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Regulation Number
884.1425
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Classification Product Code
HIR
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More FDA Info for this Product Code
Date Received
02/05/1996
Decision Date
01/16/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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