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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brush, Endometrial
510(k) Number K941298
Device Name IUMC ENDOMETRIAL SAMPLER
Applicant
Cook Ob/Gyn
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Applicant Contact RICK LYKINS
Correspondent
Cook Ob/Gyn
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Correspondent Contact RICK LYKINS
Regulation Number884.1100
Classification Product Code
HFE  
Date Received03/17/1994
Decision Date 02/13/1995
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
Recalls CDRH Recalls
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