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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name aligner, sequential
510(k) Number K143499
FOIA Releasable 510(k) K143499
Device Name eCligner
Applicant
eClear International Co., Ltd.
30 Teheranro 27 gil, Gangnam-gu
Seoul,  KR 135-915
Applicant Contact Tae Weon Kim
Correspondent
Withus Consulting
2531 Pepperdale Drive
Rowland Heights,  CA  91748
Correspondent Contact April Lee
Regulation Number872.5470
Classification Product Code
NXC  
Date Received12/10/2014
Decision Date 10/09/2015
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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