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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, semi-constrained (metal cemented acetabular component)
510(k) Number K831792
Device Name SELF-ALIGNING ACETABULAR COMPONENT
Applicant
ENDOMEDICS, INC.
4221 richmond rd., n.w.
walker,  MI  49534
Correspondent
ENDOMEDICS, INC.
4221 richmond rd., n.w.
walker,  MI  49534
Regulation Number888.3320
Classification Product Code
JDL  
Date Received06/03/1983
Decision Date 09/20/1984
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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