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K Number
K990332
Device Name
DUMEX IODOFORM PACKING STRIP
Manufacturer
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
Date Cleared
1999-04-14

(70 days)

Product Code
FRO,MXI
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

FOR GENERAL USE - DN AS DRADABADA No 2 WOND AACK WOUND MANAGEMENT CONDUIT IN

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance for any medical device. The documents are FDA 510(k) clearance letters and related forms for a "Dumex Iodoform Packing Strip." These documents confirm that the device is substantially equivalent to legally marketed predicate devices and allow it to be marketed, but they do not detail performance studies or acceptance criteria.

Therefore, I cannot provide the requested information based on the given input.

N/A