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FDA 510(k) Application Details - K013597
Device Classification Name
Instrument, Manual, Specialized Obstetric-Gynecologic
More FDA Info for this Device
510(K) Number
K013597
Device Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Applicant
COOK OB/GYN
1100 WEST MORGAN ST.
P.O. BOX 271
SPENCER, IN 47460 US
Other 510(k) Applications for this Company
Contact
CINDY RUMPLE
Other 510(k) Applications for this Contact
Regulation Number
884.4530
More FDA Info for this Regulation Number
Classification Product Code
KNA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/31/2001
Decision Date
04/17/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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