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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fibroid, Gynecological
510(k) Number K915388
Device Name LAPAROCOPIC MYOMA SCREW
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Applicant Contact MICHELLE YOUNG
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Correspondent Contact MICHELLE YOUNG
Regulation Number884.4530
Classification Product Code
HHO  
Date Received11/29/1991
Decision Date 05/18/1992
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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