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Found 2 results

510(k) Data Aggregation

K Number

Device Name

LIGHT DRAPE

Manufacturer

WRAPPED IN COMFORT

Date Cleared

2005-05-25

(184 days)

Product Code

MMP

Regulation Number

878.4370

Why did this record match?

Applicant Name (Manufacturer) :

WRAPPED IN COMFORT

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Light Drapes are designed to cover and enhance the outer appearance of phototherapy light fixtures.

Device Description

Light Drape (accessory to Neonatal Phototherapy Light)

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K Number

Device Name

INCUBATOR CAPE

Manufacturer

WRAPPED IN COMFORT

Date Cleared

2004-06-10

(73 days)

Product Code

MMP

Regulation Number

878.4370

Why did this record match?

Applicant Name (Manufacturer) :

WRAPPED IN COMFORT

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Incubator Capes are designed to cover and enhance the outer appearance of an incubator.

Device Description

Incubator Cover (accessory to Incubators)

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