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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 K042073
Device Name OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
Applicant
OLSEN MEDICAL
3001 WEST KENTUCKY ST.
LOUISVILLE,  KY  40211
Applicant Contact TERRY JOHNSON
Correspondent
OLSEN MEDICAL
3001 WEST KENTUCKY ST.
LOUISVILLE,  KY  40211
Correspondent Contact TERRY JOHNSON
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/02/2004
Decision Date 02/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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