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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: BENCOX; BENCOX MIRABO
Classification Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Product Code: LPH
Device Class: 2
Regulation Number: 888.3358
Medical Specialty: Orthopedic
Registered Establishment Name: CORENTEC CO., LTD.
Registered Establishment Number: 3009106092
Premarket Submission Number: K120924
Owner/Operator: Corentec Co., Ltd.
Owner/Operator Number: 10037247
Establishment Operations: Foreign Exporter; Manufacturer
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