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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
510(k) Number K771708
Device Name WORRELL PATELLA
Applicant
Depuy, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Depuy, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3580
Classification Product Code
HTG  
Date Received09/12/1977
Decision Date 10/06/1977
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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