DCI WATER PURIFIER

Unit, Operative Dental

DENTAL COMPONENTS, INC.

The following data is part of a premarket notification filed by Dental Components, Inc. with the FDA for Dci Water Purifier.

Pre-market Notification Details

Device IDK971727
510k NumberK971727
Device Name:DCI WATER PURIFIER
ClassificationUnit, Operative Dental
Applicant DENTAL COMPONENTS, INC. 305 NORTH SPRINGBROOK RD. Newberg,  OR  97132 -0228
ContactRichard W Hanson
CorrespondentRichard W Hanson
DENTAL COMPONENTS, INC. 305 NORTH SPRINGBROOK RD. Newberg,  OR  97132 -0228
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-09
Decision Date1997-09-12

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