SILON(R) SILICONE THERMOPLASTIC SHEETING

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(r) Silicone Thermoplastic Sheeting.

Pre-market Notification Details

Device IDK945892
510k NumberK945892
Device Name:SILON(R) SILICONE THERMOPLASTIC SHEETING
ClassificationElastomer, Silicone, For Scar Management
Applicant BIO MED SCIENCES, INC. 101 TECHNOLOGY DR. Bethlehem,  PA  18015
ContactMark E Dillon
CorrespondentMark E Dillon
BIO MED SCIENCES, INC. 101 TECHNOLOGY DR. Bethlehem,  PA  18015
Product CodeMDA  
CFR Regulation Number878.4025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-02
Decision Date1995-03-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10810050460658 K945892 000
10810050460641 K945892 000
10810050460634 K945892 000

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