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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K123608
Device Name ENDO E CLASS
Applicant
Saeyang Microtech Co., Ltd.
55 Northern Blvd.
Great Neck,  NY  11021
Applicant Contact JIGAR SHAH
Correspondent
Saeyang Microtech Co., Ltd.
55 Northern Blvd.
Great Neck,  NY  11021
Correspondent Contact JIGAR SHAH
Regulation Number872.4200
Classification Product Code
EBW  
Date Received11/21/2012
Decision Date 08/16/2013
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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