4631 DUO DELIVERY SYSTEM

Unit, Operative Dental

A-DEC, INC.

The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for 4631 Duo Delivery System.

Pre-market Notification Details

Device IDK000966
510k NumberK000966
Device Name:4631 DUO DELIVERY SYSTEM
ClassificationUnit, Operative Dental
Applicant A-DEC, INC. 2601 CRESTVIEW DR. Newberg,  OR  97132 -9257
ContactLovena Standridge
CorrespondentLovena Standridge
A-DEC, INC. 2601 CRESTVIEW DR. Newberg,  OR  97132 -9257
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-27
Decision Date2000-05-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10194665000462 K000966 000

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