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FDA 510(k) Application Details - K082436
Device Classification Name
Perineometer
More FDA Info for this Device
510(K) Number
K082436
Device Name
Perineometer
Applicant
APIMEDS, INC
5401 S. COTTONWOOD CT
GREENWOOD VILLAGE, CO 80121 US
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Contact
Kevin Walls
Other 510(k) Applications for this Contact
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
08/25/2008
Decision Date
05/29/2009
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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