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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 K061371
Device Name SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
SPENCER,  IN  47460
Applicant Contact BRENDA DAVIS
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
SPENCER,  IN  47460
Correspondent Contact BRENDA DAVIS
Regulation Number884.6180
Classification Product Code
MQL  
Date Received05/17/2006
Decision Date 08/17/2006
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
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