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FDA 510(k) Application Details - K023305
Device Classification Name
Perineometer
More FDA Info for this Device
510(K) Number
K023305
Device Name
Perineometer
Applicant
KEGELMASTER 2000 LTD.
P.O. BOX 4341
CROFTON, MD 21114 US
Other 510(k) Applications for this Company
Contact
YOLANDA SMITH
Other 510(k) Applications for this Contact
Regulation Number
884.1425
More FDA Info for this Regulation Number
Classification Product Code
HIR
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More FDA Info for this Product Code
Date Received
10/03/2002
Decision Date
12/26/2002
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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