PIEZON 250

Scaler, Ultrasonic

E.M.S. ELECTRO MEDICAL SYSTEMS S.A.

The following data is part of a premarket notification filed by E.m.s. Electro Medical Systems S.a. with the FDA for Piezon 250.

Pre-market Notification Details

Device IDK132445
510k NumberK132445
Device Name:PIEZON 250
ClassificationScaler, Ultrasonic
Applicant E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 62 FOREST ST., STE 300 Marlborough,  MA  01752
ContactCynthia Nolte
CorrespondentCynthia Nolte
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 62 FOREST ST., STE 300 Marlborough,  MA  01752
Product CodeELC  
CFR Regulation Number872.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-06
Decision Date2013-12-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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