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Found 6 results

510(k) Data Aggregation

K Number

Device Name

STERILE AMBULATORY RESERVOIR 60ML/100ML

Manufacturer

FAULDING MEDICAL DEVICE CO.

Date Cleared

1997-07-18

(409 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

FAULDING MEDICAL DEVICE CO.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

The S.P.A.R.TM Sterile Ambulatory Reservoir is intended for use with the Pharmacia Deltec CADD® Model 5800 Ambulatory Infusion Pump, manufactured and distributed by Sims Deltec Inc. St. Paul, Minnesota. The S.P.A.R.™ Medication Reservoir is intended for use as an accessory to the Pharmacia Deltic CADD® infusion punip by replacing the Deltic Medication Cassette™, Model 2050 - 50 mL and 2100 - 100 mL with the S.P.A.R. Reservoir.

Device Description

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K Number

Device Name

SAFE-CONNECT I.V. SET

Manufacturer

FAULDING MEDICAL DEVICE CO.

Date Cleared

1997-05-06

(55 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

FAULDING MEDICAL DEVICE CO.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

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K Number

Device Name

SAFE-CONNECT VIAL DISPENSING SPIKE

Manufacturer

FAULDING MEDICAL DEVICE CO.

Date Cleared

1997-05-01

(58 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

FAULDING MEDICAL DEVICE CO.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

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K Number

Device Name

SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518

Manufacturer

FAULDING MEDICAL DEVICE CO.

Date Cleared

1997-05-01

(27 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

FAULDING MEDICAL DEVICE CO.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

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K Number

Device Name

SAFE-CONNECT I.V. EXTENSION SET

Manufacturer

FAULDING MEDICAL DEVICE CO.

Date Cleared

1997-04-22

(70 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

FAULDING MEDICAL DEVICE CO.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

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K Number

Device Name

SAFECONNECT VALVE (CATALOG NO. XXXX)

Manufacturer

FAULDING MEDICAL DEVICE CO.

Date Cleared

1996-11-15

(330 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

FAULDING MEDICAL DEVICE CO.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

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