DENTAL TRAY

Unit, Operative Dental

CUSH MEDICAL PRODUCTS

The following data is part of a premarket notification filed by Cush Medical Products with the FDA for Dental Tray.

Pre-market Notification Details

Device IDK941349
510k NumberK941349
Device Name:DENTAL TRAY
ClassificationUnit, Operative Dental
Applicant CUSH MEDICAL PRODUCTS 881 MOUNTAIN VIEW DR. Piney Flats,  TN  37686
ContactSteve B Johnston
CorrespondentSteve B Johnston
CUSH MEDICAL PRODUCTS 881 MOUNTAIN VIEW DR. Piney Flats,  TN  37686
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-21
Decision Date1994-07-26

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