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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

EPI-DERM SILICONE GEL SHEETING

Manufacturer

BIODERMIS CORP.

Date Cleared

2001-01-29

(39 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K111733,K112131

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

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AI/ML Overview

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