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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 K994417
Device Name OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Applicant Contact DEBBIE SCHMITT
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Correspondent Contact DEBBIE SCHMITT
Regulation Number884.6100
Classification Product Code
MQE  
Date Received12/29/1999
Decision Date 03/01/2000
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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