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K Number
K992817
Device Name
ANTIBACTERIAL ADHESIVE BANDAGE
Manufacturer
WILLIAM FEINSTEIN & ASSOCIATES, INC.
Date Cleared
1999-11-05

(77 days)

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

Antibacterial Adhesive Bandages are to be applied to the skin for topical application. The bandages help prevent infection with minor cuts and scrapes.

Device Description

Not Found

AI/ML Overview

I'm sorry, but this document is solely focused on the FDA's communication regarding the substantial equivalence determination for an "Antibacterial Adhesive Bandage." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details for a device.

The letters are:

  • An FDA letter from November 5, 1999, confirming the "Antibacterial Adhesive Bandage" is substantially equivalent to legally marketed predicate devices.
  • A subsequent FDA letter from November 15, 2021, informing William Feinstein & Associates, Inc. of an administrative change, specifically updating the product code for the same device.

Therefore, I cannot extract the requested information from the provided text.

N/A