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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elevator, Uterine
510(k) Number K974563
Device Name COLPO CUP CVC-2000
Applicant
Clinical Innovations, Inc.
6477 S. Cottonwood St.
Murray,  UT  84107
Applicant Contact WM. DEAN WALLACE
Correspondent
Clinical Innovations, Inc.
6477 S. Cottonwood St.
Murray,  UT  84107
Correspondent Contact WM. DEAN WALLACE
Regulation Number884.4530
Classification Product Code
HDP  
Date Received12/05/1997
Decision Date 03/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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