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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, Uncemented
510(k) Number K894051
Device Name PREMIER-TOTAL HIP
Applicant
Intermedics Orthopedics
1300 E. Anderson Ln.
Bldg. C
Austin,  TX  78752
Applicant Contact THOMAS L CRAIG
Correspondent
Intermedics Orthopedics
1300 E. Anderson Ln.
Bldg. C
Austin,  TX  78752
Correspondent Contact THOMAS L CRAIG
Regulation Number888.3360
Classification Product Code
LWJ  
Date Received06/07/1989
Decision Date 08/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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