SILON SCAR STRIPS

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 Scar Strips.

Pre-market Notification Details

Device IDK982036
510k NumberK982036
Device Name:SILON SCAR STRIPS
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 Received1998-06-10
Decision Date1998-08-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10810050460313 K982036 000
10810050460306 K982036 000
10810050460290 K982036 000
10810050460283 K982036 000
10810050460276 K982036 000

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