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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elastomer, Silicone Block
510(k) Number K974482
Device Name SILIMED GLUTEAL IMPLANT
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 Number874.3620
Classification Product Code
MIB  
Date Received11/26/1997
Decision Date 02/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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