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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 Trapezium
510(k) Number K781756
Device Name SILASTIC H.P. TRAPEXIAL IMPLANT
Applicant
Dow Corning Corp. Healthcare Industries Materials
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Dow Corning Corp. Healthcare Industries Materials
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3770
Classification Product Code
KYI  
Date Received10/16/1978
Decision Date 11/15/1978
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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