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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 K770472
Device Name PROSTHESIS, VIDAL TOTAL HIP
Applicant
HOWMEDICA CORP.
4221 richmond rd., n.w.
walker,  MI  49534
Correspondent
HOWMEDICA CORP.
4221 richmond rd., n.w.
walker,  MI  49534
Regulation Number888.3320
Classification Product Code
JDL  
Date Received03/10/1977
Decision Date 03/17/1977
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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