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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 K860323
Device Name REESE ARTHRODESIS SCREW
Applicant
OSTEOTOMY GUIDE CO.
1450 S. DOBSON RD. STE 201
MESA,  AZ  85202
Applicant Contact WILLIAM REESE
Correspondent
OSTEOTOMY GUIDE CO.
1450 S. DOBSON RD. STE 201
MESA,  AZ  85202
Correspondent Contact WILLIAM REESE
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/29/1986
Decision Date 02/19/1986
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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