TRILICON BREASE PROSTHESIS DIFFERENT

Material, External Aesthetic Restoration, Used With Adhesive

BAURS KREY ASSOC., INC.

The following data is part of a premarket notification filed by Baurs Krey Assoc., Inc. with the FDA for Trilicon Brease Prosthesis Different.

Pre-market Notification Details

Device IDK841171
510k NumberK841171
Device Name:TRILICON BREASE PROSTHESIS DIFFERENT
ClassificationMaterial, External Aesthetic Restoration, Used With Adhesive
Applicant BAURS KREY ASSOC., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGBI  
CFR Regulation Number878.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-03-19
Decision Date1984-04-25

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