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Found 2 results

510(k) Data Aggregation

K Number

Device Name

IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK

Manufacturer

M-PACT WORLDWIDE MANAGEMENT CORP.

Date Cleared

1997-07-07

(75 days)

Product Code

GEC, GER

Regulation Number

878.4800

Why did this record match?

Product Code :

GEC

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The Ivalon® Instrument Wipe and PVA Knife Cleaning Block are used to clean surgical instruments and knives.

Device Description

Not Found

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K Number

Device Name

EXPANDACELL INSTRUMENT WIPE

Manufacturer

SHIPPERT MEDICAL TECHNOLOGIES CORP.

Date Cleared

1996-04-01

(48 days)

Product Code

GEC, GER

Regulation Number

878.4800

Why did this record match?

Product Code :

GEC

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe used to clean delicate instruments during a surgical procedure.

Device Description

The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe.

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