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Found 2 results

510(k) Data Aggregation

K Number

Device Name

OPERATING ROOM TOWELS

Manufacturer

BALDUR SYSTEMS CORP.

Date Cleared

1998-08-11

(81 days)

Product Code

KKX

Regulation Number

878.4370

Why did this record match?

Applicant Name (Manufacturer) :

BALDUR SYSTEMS CORP.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

INTENDED BE USED P COUERIN ﺮ INCISIO A SITE SURGICAL From AND other MICROBIAN CONTAMINATION

Device Description

Not Found

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K Number

Device Name

BALDUR NON-STERILE COTTON SPONGES

Manufacturer

BALDUR SYSTEMS CORP.

Date Cleared

1998-02-10

(83 days)

Product Code

EFQ

Regulation Number

N/A

Why did this record match?

Applicant Name (Manufacturer) :

BALDUR SYSTEMS CORP.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

A gauze is used to wipe off blood and fluids from a patient's mouth or skin.

Device Description

Class I gauze sponge 79EFQ

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