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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 K993713
Device Name RIM-FIX, ACETABULAR CUP
Applicant
Surgical Implants, Inc.
962 S. Tamiami Trl.
Sarasota,  FL  34236
Applicant Contact DOUGLAS W STUART
Correspondent
Surgical Implants, Inc.
962 S. Tamiami Trl.
Sarasota,  FL  34236
Correspondent Contact DOUGLAS W STUART
Regulation Number888.3350
Classification Product Code
JDI  
Date Received11/03/1999
Decision Date 01/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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