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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(k) Number K071064
Device Name ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA
Applicant
Ascension Orthopedics, Inc.
8700 Cameron Rd., Suite 100
Austin,  TX  78754 -3832
Applicant Contact GLEN NEALLY
Correspondent
Ascension Orthopedics, Inc.
8700 Cameron Rd., Suite 100
Austin,  TX  78754 -3832
Correspondent Contact GLEN NEALLY
Regulation Number888.3690
Classification Product Code
HSD  
Date Received04/16/2007
Decision Date 06/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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