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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 uncemented acetabular component)
510(k) Number K780330
Device Name TOTAL HIP, LORD MADREPORIC
Applicant
HOWMEDICA CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
HOWMEDICA CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number888.3330
Classification Product Code
KWA  
Date Received02/28/1978
Decision Date 05/12/1978
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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