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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K053155
Device Name VIMPLANT
Applicant
Cybermed, Inc.
#504 Sj Technoville,
Gasan-Dong 60-19, Geumcheon-Gu
Seoul,  KR 153-710
Applicant Contact SONG NAK CHOI
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact MARC M MOUSER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/14/2005
Decision Date 11/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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