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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, assisted reproduction
510(k) Number K983594
Device Name EMBRYO TRANSFER CATHETERS/SETS
Applicant
COOK OB/GYN
1100 WEST MORGAN ST.
P.O. BOX 271
spencer,  IN  47460
Applicant Contact debbie schmitt
Correspondent
COOK OB/GYN
1100 WEST MORGAN ST.
P.O. BOX 271
spencer,  IN  47460
Correspondent Contact debbie schmitt
Regulation Number884.6110
Classification Product Code
MQF  
Date Received10/13/1998
Decision Date 12/21/1998
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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