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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K991021
Device Name SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL
Applicant
Nsk Nakanishi, Inc.
340 Kamihinata, Kanuma-Shi
Tochigi-Ken,  JP 322
Applicant Contact HIROJI SEKIGUCHI
Correspondent
Nsk Nakanishi, Inc.
340 Kamihinata, Kanuma-Shi
Tochigi-Ken,  JP 322
Correspondent Contact HIROJI SEKIGUCHI
Regulation Number872.4850
Classification Product Code
ELC  
Date Received03/29/1999
Decision Date 06/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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