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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K864788
Device Name EXACTECH TOTAL HIP INSTRUMENTS
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
Date Received12/08/1986
Decision Date 12/29/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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