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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K103121
Device Name ECO-S
Applicant
Vericom Co., Ltd.
#606,5th Dongyoung Venturestel
199-32, Anyang 7-Dong,Manan-Gu
Anyang-Si, Gyeonggi-Do,  KR 430-817
Applicant Contact MYUNG-HWAN OH
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number872.3765
Classification Product Code
EBC  
Date Received10/22/2010
Decision Date 10/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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