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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, For Scar Management
510(k) Number K932214
Device Name SILON SILICONE GEL SHEET
Applicant
Bio Med Sciences, Inc.
115 Research Dr.
Bethlehem,  PA  18015
Applicant Contact MARK E DILLON
Correspondent
Bio Med Sciences, Inc.
115 Research Dr.
Bethlehem,  PA  18015
Correspondent Contact MARK E DILLON
Regulation Number878.4025
Classification Product Code
MDA  
Date Received05/07/1993
Decision Date 01/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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