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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Cement, For Clinical Use
510(k) Number K853310
Device Name SIMPLEX ENHANCEMENT MIXER
Applicant
Howmedica Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact CHARLES H LAWYER
Correspondent
Howmedica Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact CHARLES H LAWYER
Regulation Number888.4210
Classification Product Code
JDZ  
Date Received08/07/1985
Decision Date 09/11/1985
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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