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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 K890285
Device Name PROSTHETIC CEMENT REMOVER
Applicant
Albert K. Chin
3274 Alpine Rd.
Portola Valley,  CA  94025
Applicant Contact CHIN, M.D.
Correspondent
Albert K. Chin
3274 Alpine Rd.
Portola Valley,  CA  94025
Correspondent Contact CHIN, M.D.
Regulation Number888.4580
Classification Product Code
LZV  
Date Received01/19/1989
Decision Date 04/19/1989
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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