SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL

Scaler, Ultrasonic

NSK NAKANISHI, INC.

The following data is part of a premarket notification filed by Nsk Nakanishi, Inc. with the FDA for Sonic Scaler With Fiber Optic, Model Nas-l, Sonic Scaler Without Fiber Optic, Model Nas-nl.

Pre-market Notification Details

Device IDK991021
510k NumberK991021
Device Name:SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL
ClassificationScaler, Ultrasonic
Applicant NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI Tochigi-ken,  JP 322
ContactHiroji Sekiguchi
CorrespondentHiroji Sekiguchi
NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI Tochigi-ken,  JP 322
Product CodeELC  
CFR Regulation Number872.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-29
Decision Date1999-06-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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04560224977190 K991021 000

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