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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Acetabular, Hip, Prosthesis
510(k) Number K962541
Device Name REFLECTION ACETABULAR REINFORCEMENT RINGS
Applicant
SMITH & NEPHEW RICHARDS, INC.
1450 E. BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact THOMAS L GRAIG
Correspondent
SMITH & NEPHEW RICHARDS, INC.
1450 E. BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact THOMAS L GRAIG
Regulation Number878.3300
Classification Product Code
JDJ  
Date Received06/28/1996
Decision Date 09/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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