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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K945186
Device Name CONSENUS HIP SYSTEM -- ACETABULAR REAMER
Applicant
U.S. Medical Products, Inc.
912 S. Capital Of Texas Hwy.
Suite 100
Austin,  TX  78746
Applicant Contact WILLIAM N THOMPSON
Correspondent
U.S. Medical Products, Inc.
912 S. Capital Of Texas Hwy.
Suite 100
Austin,  TX  78746
Correspondent Contact WILLIAM N THOMPSON
Regulation Number878.4820
Classification Product Code
HWE  
Subsequent Product Code
KIJ  
Date Received10/24/1994
Decision Date 01/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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