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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protractor
510(k) Number K861576
Device Name SHORTENING OSTEOTOMY GUIDE
Applicant
Osteotomy Guide Co.
1450 S. Dobson Rd. Suite 201
Mesa,  AZ  85202
Applicant Contact WILLIAM REESE
Correspondent
Osteotomy Guide Co.
1450 S. Dobson Rd. Suite 201
Mesa,  AZ  85202
Correspondent Contact WILLIAM REESE
Regulation Number888.4600
Classification Product Code
HTH  
Date Received04/28/1986
Decision Date 05/12/1986
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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