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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 K944946
Device Name CONSENUS HIP SYSTEM FEMORAL CANAL STARTER 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 Codes
HSZ   KIJ  
Date Received10/07/1994
Decision Date 02/01/1995
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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