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K Number
K011618
Device Name
CALGITROL AG SILVER ALGINATE WOUND DRESSING
Manufacturer
ADRI
Date Cleared
2002-11-15

(539 days)

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

Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers 1st and 2nd degree burns; donor sites

Device Description

CALGITROL™ Ag Silver Alginate Foam and Gel Foam Dressings with or without Maltodextrin

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Calgitrol™ AG Silver Alginate Foam and Gel Foam Dressings). This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory approval letter, not a study report.

Therefore, I cannot extract the requested information as it is not present in the provided text.

N/A