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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K043578
Device Name THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM
Applicant
Solco Biomedical Co., Ltd.
7612 Barnum Rd.
Bethesda,  MD  20817
Applicant Contact SAEYOUNG AHN
Correspondent
Solco Biomedical Co., Ltd.
7612 Barnum Rd.
Bethesda,  MD  20817
Correspondent Contact SAEYOUNG AHN
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received12/28/2004
Decision Date 03/07/2005
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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