J. MORITA AZ ULTRASONIC SYSTEM

Scaler, Ultrasonic

J. MORITA USA, INC.

The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for J. Morita Az Ultrasonic System.

Pre-market Notification Details

Device IDK053030
510k NumberK053030
Device Name:J. MORITA AZ ULTRASONIC SYSTEM
ClassificationScaler, Ultrasonic
Applicant J. MORITA USA, INC. 9 MASON Irvine,  CA  92618
ContactHoward Rowe
CorrespondentHoward Rowe
J. MORITA USA, INC. 9 MASON Irvine,  CA  92618
Product CodeELC  
CFR Regulation Number872.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-27
Decision Date2005-11-07

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