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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K160102
Device Name Amber Mill Series and Amber Press Series
Applicant
Hass Corp.
77-14, Gwahakdanji-Ro
Gangneung-Si,  KR 210-340
Applicant Contact YONGSU KIM
Correspondent
LK Consulting Group USA, Inc.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Correspondent Contact PRISCILLA CHUNG
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/19/2016
Decision Date 07/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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