RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT

Unit, Operative Dental

PELTON & CRANE CO.

The following data is part of a premarket notification filed by Pelton & Crane Co. with the FDA for Resubmitted Water Purifier For Use W/dental Treat.

Pre-market Notification Details

Device IDK901672
510k NumberK901672
Device Name:RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT
ClassificationUnit, Operative Dental
Applicant PELTON & CRANE CO. P.O. BOX 7800 Charlotte,  NC  28241 -7800
ContactJames R Grieger
CorrespondentJames R Grieger
PELTON & CRANE CO. P.O. BOX 7800 Charlotte,  NC  28241 -7800
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-10
Decision Date1990-07-06

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