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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name microtools, assisted reproduction (pipettes)
510(k) Number K033903
Device Name MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,
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 Number884.6130
Classification Product Code
MQH  
Date Received12/17/2003
Decision Date 01/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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