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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 K941528
Device Name PEARL PACKING FORCEPS
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Applicant Contact RICK LYKINS
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Correspondent Contact RICK LYKINS
Regulation Number884.4530
Classification Product Code
HCZ  
Date Received03/30/1994
Decision Date 05/12/1994
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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