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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator, Culdoscopic (And Accessories)
510(k) Number K936026
Device Name COOK LAPAROSCOPIC MINI RETRACTOR SET
Applicant
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Applicant Contact RICK LYKINS
Correspondent
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Correspondent Contact RICK LYKINS
Regulation Number884.4160
Classification Product Code
HFI  
Date Received12/17/1993
Decision Date 03/11/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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