ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD

Unit, X-ray, Extraoral With Timer

PELTON & CRANE CO.

The following data is part of a premarket notification filed by Pelton & Crane Co. with the FDA for Orthophos Plus And Orthophos Plus/cd.

Pre-market Notification Details

Device IDK972249
510k NumberK972249
Device Name:ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD
ClassificationUnit, X-ray, Extraoral With Timer
Applicant PELTON & CRANE CO. 49 PLAIN ST. North Atteboro,,  MA  02760
ContactSheila Hemeon-heyer
CorrespondentSheila Hemeon-heyer
PELTON & CRANE CO. 49 PLAIN ST. North Atteboro,,  MA  02760
Product CodeEHD  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-16
Decision Date1997-09-12
Summary:summary

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