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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 K120924
Device Name BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG
Applicant
CORENTEC CO., LTD
11TH CHUNGHO TOWER
748-1 BANPO 1 DONG
SEOCHO GU, SEOUL,  KR 137-040
Applicant Contact J.S. DANIEL
Correspondent
CORENTEC CO., LTD
11TH CHUNGHO TOWER
748-1 BANPO 1 DONG
SEOCHO GU, SEOUL,  KR 137-040
Correspondent Contact J.S. DANIEL
Regulation Number888.3358
Classification Product Code
LPH  
Date Received03/27/2012
Decision Date 09/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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