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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Chin, Internal
510(k) Number K981850
Device Name SILIMED CHIN IMPLANTS
Applicant
Silimed, LLC
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
Silimed, LLC
P.O. Box 4341
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number878.3550
Classification Product Code
FWP  
Date Received05/26/1998
Decision Date 07/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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