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K Number
K033391
Device Name
MEDICAL MAGGOTS
Manufacturer
RONALD A. SHERMAN
Date Cleared
2004-01-12

(81 days)

Product Code
NQK
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
K072438,K102827,K123449
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post surgical wounds.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for "Medical Maggots" and does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter confirms substantial equivalence to a predicate device for specific indications for use, but it does not detail any performance metrics or clinical study results.

Therefore, I cannot provide the requested information based on the provided text.

N/A