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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
Models H1.A11.0000-001, H1.A11.0000-002
Device Name BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG
Original Applicant
CORENTEC CO., LTD
11th chungho tower
748-1 banpo 1 dong
seocho gu, seoul,  KS 137-040
Original Contact j.s. daniel
Regulation Number888.3358
Classification Product Code
LPH  
Date Received03/27/2012
Decision Date 09/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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