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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K863805
Device Name MILLER/GALANTE TOTAL KNEE POR COATED PATELLAR DOME
Applicant
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581
Applicant Contact MAX SHERMAN
Correspondent
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581
Correspondent Contact MAX SHERMAN
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/30/1986
Decision Date 12/02/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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