SILON SILICONE GEL SHEET

Elastomer, Silicone, For Scar Management

BIO MED SCIENCES, INC.

The following data is part of a premarket notification filed by Bio Med Sciences, Inc. with the FDA for Silon Silicone Gel Sheet.

Pre-market Notification Details

Device IDK932214
510k NumberK932214
Device Name:SILON SILICONE GEL SHEET
ClassificationElastomer, Silicone, For Scar Management
Applicant BIO MED SCIENCES, INC. 115 RESEARCH DR. Bethlehem,  PA  18015
ContactMark E Dillon
CorrespondentMark E Dillon
BIO MED SCIENCES, INC. 115 RESEARCH DR. Bethlehem,  PA  18015
Product CodeMDA  
CFR Regulation Number878.4025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-07
Decision Date1994-01-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10810050460184 K932214 000

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