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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K882934
Device Name CASF CANCELLOUS BONE SCREW, BT650
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 Number888.3040
Classification Product Code
HWC  
Date Received07/13/1988
Decision Date 10/13/1988
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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