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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, Cemented
510(k) Number K011774
Device Name R120 MODULAR TOTAL HIP SYSTEM
Applicant
Osteoimplant Technology, Inc.
11201 Pepper Rd.
Hunt Valley,  MD  21031
Applicant Contact SAM SON
Correspondent
Osteoimplant Technology, Inc.
11201 Pepper Rd.
Hunt Valley,  MD  21031
Correspondent Contact SAM SON
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
LPH  
Date Received06/07/2001
Decision Date 09/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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