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FDA 510(k) Application Details - K983587
Device Classification Name
Catheter, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K983587
Device Name
Catheter, Assisted Reproduction
Applicant
COOK OB/GYN
1100 WEST MORGAN ST.
P.O. BOX 271
SPENCER, IN 47460 US
Other 510(k) Applications for this Company
Contact
BRENDA DAVIS
Other 510(k) Applications for this Contact
Regulation Number
884.6110
More FDA Info for this Regulation Number
Classification Product Code
MQF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/13/1998
Decision Date
12/16/1998
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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