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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Curette, Suction, Endometrial (And Accessories)
510(k) Number K000974
Device Name FOWLER ENDOCURETTE, MODEL CUR-XXX
Applicant
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047 -1048
Applicant Contact KEVIN L CORNWELL
Correspondent
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047 -1048
Correspondent Contact KEVIN L CORNWELL
Regulation Number884.1175
Classification Product Code
HHK  
Date Received03/27/2000
Decision Date 05/23/2000
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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