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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 K990003
Device Name J-SERIES OMEGA 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 Number888.3358
Classification Product Code
LPH  
Date Received01/04/1999
Decision Date 02/24/1999
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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