OLEEVA FOAM

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 Oleeva Foam.

Pre-market Notification Details

Device IDK002109
510k NumberK002109
Device Name:OLEEVA FOAM
ClassificationElastomer, Silicone, For Scar Management
Applicant BIO MED SCIENCES, INC. 1111 HAMILTON ST. Allentown,  PA  18101
ContactMark E Dillon
CorrespondentMark E Dillon
BIO MED SCIENCES, INC. 1111 HAMILTON ST. Allentown,  PA  18101
Product CodeMDA  
CFR Regulation Number878.4025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-12
Decision Date2000-08-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10810050460269 K002109 000
10810050460177 K002109 000
10810050460191 K002109 000
10810050460207 K002109 000
10810050460214 K002109 000
10810050460221 K002109 000
10810050460238 K002109 000
10810050460245 K002109 000
10810050460252 K002109 000
10810050460160 K002109 000

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