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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 K090950
Device Name BONE PLUS BCP
Applicant
Megagen Implant Co., Ltd.
13340 E Firestone Blvd.
Suite J
Santa Fe Springs,  CA  90670
Applicant Contact JOYCE BANG
Correspondent
Megagen Implant Co., Ltd.
13340 E Firestone Blvd.
Suite J
Santa Fe Springs,  CA  90670
Correspondent Contact JOYCE BANG
Regulation Number872.3930
Classification Product Code
LYC  
Date Received04/03/2009
Decision Date 07/02/2010
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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