KODAK DENTAL BARRIER PAC

Film, Radiographic

EASTMAN KODAK COMPANY

The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Dental Barrier Pac.

Pre-market Notification Details

Device IDK884827
510k NumberK884827
Device Name:KODAK DENTAL BARRIER PAC
ClassificationFilm, Radiographic
Applicant EASTMAN KODAK COMPANY 343 STATE ST. Rochester,  NY  14650
ContactNorman H Geil
CorrespondentNorman H Geil
EASTMAN KODAK COMPANY 343 STATE ST. Rochester,  NY  14650
Product CodeIWZ  
CFR Regulation Number892.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-18
Decision Date1989-01-30

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