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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 K821713
Device Name POROCOAT LOW PROFILE METAL BACKED CUP
Applicant
Depuy, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Depuy, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3350
Classification Product Code
JDI  
Date Received06/10/1982
Decision Date 08/20/1982
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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