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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K122240
Device Name BONE PLUS BCP EAGLE EYE
Applicant
Megagen Implant Co., Ltd.
325 N. Puente St., Unit B
Brea,  CA  92821
Applicant Contact APRIL LEE
Correspondent
Megagen Implant Co., Ltd.
325 N. Puente St., Unit B
Brea,  CA  92821
Correspondent Contact APRIL LEE
Regulation Number872.3930
Classification Product Code
LYC  
Date Received07/27/2012
Decision Date 08/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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