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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 Interlaminal
510(k) Number K870085
Device Name ANTERIOR SPINAL FIXATION PLATE
Applicant
Terray Manufacturing, Inc.
24 Mcgonigal St. W.
Arnprior
Ontario K7s 1l8,  CA
Applicant Contact RAY DESJARDINS
Correspondent
Terray Manufacturing, Inc.
24 Mcgonigal St. W.
Arnprior
Ontario K7s 1l8,  CA
Correspondent Contact RAY DESJARDINS
Regulation Number888.3050
Classification Product Code
KWP  
Date Received01/08/1987
Decision Date 06/30/1987
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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