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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name media, reproductive
510(k) Number K002385
Device Name COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
Applicant
COOK OB/GYN
1100 WEST MORGAN ST.
P.O. BOX 271
SPENCER,  IN  47460
Applicant Contact BRENDA DAVIS
Correspondent
COOK OB/GYN
1100 WEST MORGAN ST.
P.O. BOX 271
SPENCER,  IN  47460
Correspondent Contact BRENDA DAVIS
Regulation Number884.6180
Classification Product Code
MQL  
Date Received08/04/2000
Decision Date 09/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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