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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Fixation, Spinal Intervertebral Body
510(k) Number K882871
Device Name CASF DRILL GUIDE DG 170
Applicant
Terray Manufacturing, Inc.
24 Mcgonigal St. W.
Arnprior
Ontario K7s 1l8,  CA
Applicant Contact JUDY WILSON
Correspondent
Terray Manufacturing, Inc.
24 Mcgonigal St. W.
Arnprior
Ontario K7s 1l8,  CA
Correspondent Contact JUDY WILSON
Regulation Number888.4540
Classification Product Code
LYQ  
Date Received07/11/1988
Decision Date 09/23/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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