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K Number
K974890
Device Name
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002
Manufacturer
ACUTEK ADHESIVE SPECIALTIES, INC.
Date Cleared
1998-10-13

(287 days)

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

The Hydrocolloid Dressing is intended for the management of lightly to moderately exudating wounds by absorbing exudate and by maintaining a moist wound environment. The moist wound environment supports autolytic debridement. The dressing backing allows for gas exchange. The dressing is indicated for use in the following types of wounds: venous stasis ulcers, pressure ulcers, surgical incision sites, and minor burns.

Device Description

Not Found

AI/ML Overview

I'm sorry, but this document does not contain information about acceptance criteria or a study proving device performance. This is a 510(k) clearance letter from the FDA for a wound dressing, indicating that the device is substantially equivalent to a predicate device and can be marketed. It outlines the indications for use and certain labeling restrictions.

Therefore, I cannot provide the requested table or answer the specific questions about a study and its details as they are not present in the provided text.

N/A