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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 K910874
Device Name THORACIC ANTERIOR SPINAL FIXATION PLATE
Applicant
Terray Manufacturing, Inc.
24 Mcgonigal St. W.
Arnprior
Ontario K7s 1l8,  CA
Applicant Contact STEPHEN GILBERT
Correspondent
Terray Manufacturing, Inc.
24 Mcgonigal St. W.
Arnprior
Ontario K7s 1l8,  CA
Correspondent Contact STEPHEN GILBERT
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/01/1991
Decision Date 02/03/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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