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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 K964509
Device Name IMPLEX A-240 HEP ACETABULAR CUP SYSTEM
Applicant
Implex Corp.
1700 Rockville Pike, Suite 450
Rockville,  MD  20852
Applicant Contact GLENN N BYRD
Correspondent
Implex Corp.
1700 Rockville Pike, Suite 450
Rockville,  MD  20852
Correspondent Contact GLENN N BYRD
Regulation Number888.3358
Classification Product Code
LPH  
Date Received11/08/1996
Decision Date 06/19/1997
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
Recalls CDRH Recalls
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