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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K092162
Device Name 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM
Applicant
SOLCO BIOMEDICAL CO., LTD.
155 GIBBS ST., SUITE 510
ROCKVILLE,  MD  20850
Applicant Contact SAEYOUNG AHN
Correspondent
SOLCO BIOMEDICAL CO., LTD.
155 GIBBS ST., SUITE 510
ROCKVILLE,  MD  20850
Correspondent Contact SAEYOUNG AHN
Regulation Number888.3080
Classification Product Code
MAX  
Date Received07/16/2009
Decision Date 01/06/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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