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K Number
K082089
Device Name
PRUMYX CREAM
Manufacturer
PRUGEN, INC.
Date Cleared
2009-01-13

(173 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K041342
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

FOR TOPICAL DERMATOLOGICAL USE ONLY

Description Rx Product:
Under the supervision of a healthcare professional, PruMyx Cream is indicated to manage and relieve the burning and itching experienced with various-types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis. PruMyx Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Description OTC Product:
PruMyx Cream helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation. PruMyx Cream may also be used to soothe minor bums, including sunburn.

Device Description

PruMyx™ Cream is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for both Prescription (requiring a physician diagnosis disease state) and over-the-counter (OTC) use.

AI/ML Overview

This document refers to PruMyx™ Cream, a medical device. There is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the provided text.

The document is a 510(k) premarket notification for a medical device (PruMyx™ Cream) and a letter from the FDA determining substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing detailed acceptance criteria and study results.

The key points from the provided text are:

  • Substantial Equivalence: PruMyx™ Cream is deemed substantially equivalent to MimyX® Cream (cleared under K041342).
  • Intended Use: The device is for topical application to manage and relieve burning and itching associated with various dermatoses (prescription use) and to nourish skin and relieve burning/itching from common skin irritation and minor burns (OTC use).
  • Safety and Efficacy: The summary states, "Functional and performance testing has been conducted to assess the safety and efficacy PruMyx™ Cream and results are satisfactory," but no details of this testing are provided.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text.

N/A