BURBANK TENACULUM

Tenaculum, Uterine

VASCULAR CONTROL SYSTEMS, INC

The following data is part of a premarket notification filed by Vascular Control Systems, Inc with the FDA for Burbank Tenaculum.

Pre-market Notification Details

Device IDK060573
510k NumberK060573
Device Name:BURBANK TENACULUM
ClassificationTenaculum, Uterine
Applicant VASCULAR CONTROL SYSTEMS, INC 32236-F PASEO ADELANTO San Juan Capistrano,  CA  92675
ContactKathleen Roberts
CorrespondentTamas Borsai
TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton,  CT  06470
Product CodeHDC  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-03-06
Decision Date2006-04-21
Summary:summary

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