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510(k) Data Aggregation

K Number

Device Name

BURLEW INFANT HOOD

Manufacturer

PROMEDIC, INC.

Date Cleared

1996-07-15

(39 days)

Product Code

FOG

Regulation Number

868.5700

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Search-Everything :

Matched: '868.5700'

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The device indicated for patients who need to be placed in an oxygen enriched environment.

Device Description

Disposable Infant hood with drape

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