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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 K192450
Device Name Precision Casting Solutions Total Hip System
Applicant
Precision Casting Solution, LLC
200031 Henrici Rd.
Oregon City,  OR  97045
Applicant Contact Jim Moore
Correspondent
Precision Casting Solution, LLC
200031 Henrici Rd.
Oregon City,  OR  97045
Correspondent Contact Jim Moore
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received09/06/2019
Decision Date 12/17/2019
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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