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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 K073058
Device Name RESCUE INTERNAL IMPLANT SYSTEM
Applicant
Megagen Co., Ltd.
13340 E Firestone Blvd.
Suite J
Santa Fe Springs,  CA  90670
Applicant Contact STEVE CHANG
Correspondent
Megagen Co., Ltd.
13340 E Firestone Blvd.
Suite J
Santa Fe Springs,  CA  90670
Correspondent Contact STEVE CHANG
Regulation Number872.3640
Classification Product Code
DZE  
Date Received10/30/2007
Decision Date 04/11/2008
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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