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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 K834035
Device Name UNIVERSAL SELF-ALIGNING ACETABULAR COM
Applicant
Orthopedic Equipment Co., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Orthopedic Equipment Co., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3350
Classification Product Code
JDI  
Date Received11/23/1983
Decision Date 06/19/1984
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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