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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 K202786
Device Name Dental Low-speed Handpieces and Accessories
Applicant
MicroP Technology (Taiwan), Inc.
No.50, Zhongxiao 2nd St., East Dist, Chiayi City 600, Taiwan
(R.O.C)
Chiayi City,  TW 600
Applicant Contact Ina Lin
Correspondent
MicroP Technology (Taiwan), Inc.
No.50, Zhongxiao 2nd St., East Dist, Chiayi City 600, Taiwan
(R.O.C)
Chiayi City,  TW 600
Correspondent Contact Ina Lin
Regulation Number872.4200
Classification Product Code
EFB  
Subsequent Product Code
EGS  
Date Received09/22/2020
Decision Date 09/03/2021
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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