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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Wrist, Carpal Lunate
510(k) Number K864491
Device Name SWANSON TITANIUM CARPAL LUNATE IMPLANT
Applicant
DOW CORNING WRIGHT
P.O. BOX 100
ARLINGTON,  TN  38002
Applicant Contact ANTHONY J LENTZ
Correspondent
DOW CORNING WRIGHT
P.O. BOX 100
ARLINGTON,  TN  38002
Correspondent Contact ANTHONY J LENTZ
Regulation Number888.3750
Classification Product Code
KWN  
Date Received11/13/1986
Decision Date 04/15/1987
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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