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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, Porous Uncemented
510(k) Number K022382
Device Name RHS ACETABULAR COMPONENT
Applicant
Signal Medical Corp.
3777 Lapeer Rd. 3-C
Port Huron,  MI  48060
Applicant Contact LOUIS SERAFIN
Correspondent
Signal Medical Corp.
3777 Lapeer Rd. 3-C
Port Huron,  MI  48060
Correspondent Contact LOUIS SERAFIN
Regulation Number888.3358
Classification Product Code
LPH  
Date Received07/22/2002
Decision Date 10/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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