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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 K933229
Device Name APOLLO KNEE FEMORAL COMPONENT
Applicant
INTERMEDICS ORTHOPEDICS
1300-C EAST ANDERSON LN.
AUSTIN,  TX  78752
Applicant Contact JOANN RINGER
Correspondent
INTERMEDICS ORTHOPEDICS
1300-C EAST ANDERSON LN.
AUSTIN,  TX  78752
Correspondent Contact JOANN RINGER
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/02/1993
Decision Date 01/27/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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