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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 K800800
Device Name PATELLAR COMPONENT FOR LUBINUS PATELLAR
Applicant
Waldemar Link GmbH & Co. KG
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Waldemar Link GmbH & Co. KG
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3580
Classification Product Code
HTG  
Date Received04/10/1980
Decision Date 04/21/1980
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
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