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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K041655
Device Name BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)
Applicant
Cowellmedi Co., Ltd.
161 Little Bay Rd.
Newington,  NH  03801
Applicant Contact DAE KYU CHANG
Correspondent
Cowellmedi Co., Ltd.
161 Little Bay Rd.
Newington,  NH  03801
Correspondent Contact DAE KYU CHANG
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/18/2004
Decision Date 09/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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