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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, assisted reproduction
510(k) Number K983593
Device Name OVUM PICK-UP ASPIRATION NEEDLES
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 Number884.6100
Classification Product Code
MQE  
Date Received10/13/1998
Decision Date 01/21/1999
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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