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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K973321
Device Name HOFFMANN II COMPACT PERIARTICULAR CLAMP
Applicant
Howmedica, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070 -2584
Applicant Contact JOHN DICHIARA
Correspondent
Howmedica, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070 -2584
Correspondent Contact JOHN DICHIARA
Regulation Number888.3030
Classification Product Code
KTT  
Date Received09/04/1997
Decision Date 11/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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