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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/Polymer, Cemented
510(k) Number K811151
Device Name COLLARLESS TOTAL HIP FEMORAL COMP. SYS
Applicant
Howmedica Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Howmedica Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3350
Classification Product Code
JDI  
Date Received04/27/1981
Decision Date 05/15/1981
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
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