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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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K935523
Device Name NATURAL-KNEE(R)/APOLLO(TM) KNEE
Applicant
Intermedics Orthopedics
1300-C E. Anderson Ln.
Austin,  TX  78752
Applicant Contact JOANN RINGER
Correspondent
Intermedics Orthopedics
1300-C E. Anderson Ln.
Austin,  TX  78752
Correspondent Contact JOANN RINGER
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/18/1993
Decision Date 06/06/1995
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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