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K Number
K990179
Device Name
BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD
Manufacturer
NORTRADE MEDICAL, INC.
Date Cleared
1999-08-13

(205 days)

Product Code
MGQ,MGO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. For first aid use on minor burns including sunburn, cuts, scrapes, and abrasions.
  2. Relieves Pain.
  3. Cools and Soothes.
  4. Moistens.
  5. Non-Irritating
  6. Bacteriostatic
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Burnfree Sterile Wound and Burn Dressing" and "Burnfree Pain Relieving Gel" products. It confirms that the devices are substantially equivalent to previously marketed devices and outlines regulatory responsibilities.

This document does not contain information about:

  1. Acceptance criteria and reported device performance.
  2. Sample sizes, data provenance, or details of a study.
  3. Number of experts, their qualifications, or adjudication methods.
  4. Multi-reader multi-case (MRMC) comparative effectiveness studies.
  5. Standalone algorithm performance.
  6. Type of ground truth used.
  7. Sample size for the training set or how its ground truth was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study details based on the provided text.

N/A