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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 K030078
Device Name BURBANK TENACULUM, MODEL 09-0011-01
Applicant
Vascular Control Systems, Inc.
32236 Paseo Adelanto, Suite E
San Juan Capistrano,  CA  92675
Applicant Contact AL MEMMOLO
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact HEINZ JOERG STENEBERG
Regulation Number884.4530
Classification Product Code
HDC  
Date Received01/09/2003
Decision Date 01/24/2003
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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