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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K140234
Device Name ASPIRON ACP SYSTEM
Applicant
U&I Corp.
20, Sandan-Ro 76beon-Gil(Rd)
Uijeongbu-Si, Gyeonggi-Do,  KR 480-859
Applicant Contact YOUNG-GEUN KIM
Correspondent
U&I Corp.
20, Sandan-Ro 76beon-Gil(Rd)
Uijeongbu-Si, Gyeonggi-Do,  KR 480-859
Correspondent Contact YOUNG-GEUN KIM
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received01/29/2014
Decision Date 06/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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