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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name forceps, surgical, gynecological
510(k) Number K903707
Device Name DEFLECTING WIRE GRASPER
Applicant
COOK, INC.
1100 WEST MORGAN ST.
P.O. BOX 271
SPENCER,  IN  47460
Applicant Contact MICHELLE YOUNG
Correspondent
COOK, INC.
1100 WEST MORGAN ST.
P.O. BOX 271
SPENCER,  IN  47460
Correspondent Contact MICHELLE YOUNG
Regulation Number884.4530
Classification Product Code
HCZ  
Date Received08/15/1990
Decision Date 09/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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