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FDA 510(k) Application Details - K994079
Device Classification Name
Perineometer
More FDA Info for this Device
510(K) Number
K994079
Device Name
Perineometer
Applicant
DESCHUTES MEDICAL PRODUCTS, INC.
1011 S.W. EMKAY DR., SUITE 104
BEND, OR 97702 US
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Contact
DENISE BESTWICK
Other 510(k) Applications for this Contact
Regulation Number
884.1425
More FDA Info for this Regulation Number
Classification Product Code
HIR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/02/1999
Decision Date
03/01/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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