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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 K031304
Device Name SYDNEY IVF PVP
Applicant
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 227
Spencer,  IN  47460
Applicant Contact BRENDA DAVIS
Correspondent
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 227
Spencer,  IN  47460
Correspondent Contact BRENDA DAVIS
Regulation Number884.6180
Classification Product Code
MQL  
Date Received04/24/2003
Decision Date 03/23/2004
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
Predetermined Change
Control Plan Authorized		 No
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