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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K080305
Device Name NEXCOMP AND META ETCHANT
Applicant
Meta Biomed Co., Ltd.
414-12 Mo Choong Dong
Cheong Ju
Cheung City, Chung Buk,  KR 441-12
Applicant Contact TAE-HOON KIM
Correspondent
Meta Biomed Co., Ltd.
414-12 Mo Choong Dong
Cheong Ju
Cheung City, Chung Buk,  KR 441-12
Correspondent Contact TAE-HOON KIM
Regulation Number872.3690
Classification Product Code
EBF  
Date Received02/05/2008
Decision Date 04/07/2008
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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