ULTRASONIC SCALER

Scaler, Ultrasonic

NAKANISHI, INC.

The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Ultrasonic Scaler.

Pre-market Notification Details

Device IDK113717
510k NumberK113717
Device Name:ULTRASONIC SCALER
ClassificationScaler, Ultrasonic
Applicant NAKANISHI, INC. 1201 RICHARDSON DRIVE SUITE 280 Richardson,  TX  75080
ContactDiane Rutherford
CorrespondentDiane Rutherford
NAKANISHI, INC. 1201 RICHARDSON DRIVE SUITE 280 Richardson,  TX  75080
Product CodeELC  
CFR Regulation Number872.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-19
Decision Date2013-03-05
Summary:summary

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