VITA RESPONSE

Powder, Porcelain

VIDENT

The following data is part of a premarket notification filed by Vident with the FDA for Vita Response.

Pre-market Notification Details

Device IDK000597
510k NumberK000597
Device Name:VITA RESPONSE
ClassificationPowder, Porcelain
Applicant VIDENT 3150 EAST BIRCH ST. Brea,  CA  92821
ContactBarbara J Lewandowski
CorrespondentBarbara J Lewandowski
VIDENT 3150 EAST BIRCH ST. Brea,  CA  92821
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-22
Decision Date2000-05-17

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