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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 K141886
Device Name MDK HANDPIECES
Applicant
MODERN KOREA CO., LTD.
2651 E. CHAPMAN AVE. STE 110
FULLERTON,  CA  92831
Applicant Contact Priscilla Chung
Correspondent
MODERN KOREA CO., LTD.
2651 E. CHAPMAN AVE. STE 110
FULLERTON,  CA  92831
Correspondent Contact Priscilla Chung
Regulation Number872.4200
Classification Product Code
EFB  
Date Received07/14/2014
Decision Date 05/13/2015
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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