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510(k) Data Aggregation

K Number

Device Name

Dental Barrier and Sleeves

Manufacturer

Fomed Industries, Inc.

Date Cleared

2025-06-10

(91 days)

Product Code

PEM

Regulation Number

878.4370

Why did this record match?

Applicant Name (Manufacturer) :

Fomed Industries, Inc.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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