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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(k) Number K905580
Device Name TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO
Applicant
Exactech, Inc.
2210 NW 28th St.
Gainesville,  FL  32605
Applicant Contact WILLIAM PETTY
Correspondent
Exactech, Inc.
2210 NW 28th St.
Gainesville,  FL  32605
Correspondent Contact WILLIAM PETTY
Regulation Number888.3690
Classification Product Code
HSD  
Date Received12/12/1990
Decision Date 03/12/1991
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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