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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Femoral, Resurfacing
510(k) Number K842233
Device Name NEW JERSEY FEMORAL RESURFACING COMPONENT
Applicant
Endomedics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Endomedics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3400
Classification Product Code
KXA  
Date Received06/05/1984
Decision Date 07/20/1984
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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