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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Cement Removal Extraction
510(k) Number K904180
Device Name PROSTHETIC CEMENT REMOVER
Applicant
Origin Medsystems, Inc.
1900 S. Norfolk St.,
Suite 312
San Mateo,  CA  94403
Applicant Contact RICHARD RUSH
Correspondent
Origin Medsystems, Inc.
1900 S. Norfolk St.,
Suite 312
San Mateo,  CA  94403
Correspondent Contact RICHARD RUSH
Regulation Number888.4580
Classification Product Code
LZV  
Date Received09/11/1990
Decision Date 11/20/1990
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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