KWIX-BITE X-RAY FILM HOLDER

Holder, Film, X-ray

HENRY SCHEIN, INC.

The following data is part of a premarket notification filed by Henry Schein, Inc. with the FDA for Kwix-bite X-ray Film Holder.

Pre-market Notification Details

Device IDK801079
510k NumberK801079
Device Name:KWIX-BITE X-RAY FILM HOLDER
ClassificationHolder, Film, X-ray
Applicant HENRY SCHEIN, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEGZ  
CFR Regulation Number872.1905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-05-07
Decision Date1980-05-20

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