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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, Cemented
510(k) Number K011887
Device Name AVALON CUP SYSTEM
Applicant
Orthopedic Source, Inc.
P.O. Box 307
Loomis,  CA  95650
Applicant Contact STEVEN L MANDELL
Correspondent
Orthopedic Source, Inc.
P.O. Box 307
Loomis,  CA  95650
Correspondent Contact STEVEN L MANDELL
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
LZO  
Date Received06/18/2001
Decision Date 12/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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