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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, Hemi-, Femoral, Metal
510(k) Number K800207
Device Name UHR UNIVERSAL6HIP REPLACEMENT
Applicant
OSTEONICS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
OSTEONICS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.3360
Classification Product Code
KWL  
Date Received01/30/1980
Decision Date 02/11/1980
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
Recalls CDRH Recalls
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