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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name handpiece, air-powered, dental
510(k) Number K173943
Device Name Dental High-speed Handpiece and Accessories
Applicant
MicroP Technology (Taiwan), Inc.
No.40, Junghe Tsuen, Minshiung Township
Chiayi County,  TW 621
Applicant Contact Ina Lin
Correspondent
MicroP Technology (Taiwan), Inc.
No.40, Junghe Tsuen, Minshiung Township
Chiayi County,  TW 621
Correspondent Contact Ina Lin
Regulation Number872.4200
Classification Product Code
EFB  
Date Received12/26/2017
Decision Date 07/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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