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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tenaculum, Uterine
510(k) Number K060573
Device Name BURBANK TENACULUM
Applicant
Vascular Control Systems, Inc.
32236-F Paseo Adelanto
San Juan Capistrano,  CA  92675
Applicant Contact KATHLEEN ROBERTS
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number884.4530
Classification Product Code
HDC  
Subsequent Product Code
DXC  
Date Received03/06/2006
Decision Date 04/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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