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K Number
K990180
Device Name
BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING
Manufacturer
NORTRADE MEDICAL, INC.
Date Cleared
1999-08-13

(205 days)

Product Code
MGQ
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. First aid for burns, scalds, cuts, and abrasions.
  2. Relieves Pain.
  3. Cools and Soothes.
  4. Moistens.
  5. Non-Adherent
  6. Bacteriostatic
Device Description

Not Found

AI/ML Overview

This looks like a 510(k) clearance letter for a medical device from 1999, specifically for "Burnfree Sterile Wound and Burn Dressing," "Burnfree 1/8 oz. Sterile Pain Relieving Gel," and "Burnfree Pain Relieving Gel."

Unfortunately, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

This type of FDA letter (a 510(k) clearance) focuses on demonstrating "substantial equivalence" to a predicate device already on the market. It doesn't typically require the submission of new clinical trial data or detailed performance studies with acceptance criteria in the same way a Premarket Approval (PMA) would.

Therefore, I cannot provide the requested information from this document. The document primarily states:

  • The devices are substantially equivalent to pre-amendments devices.
  • The indications for use for the Burnfree Sterile Burn and Wound Dressing (e.g., first aid for burns, relieves pain, cools and soothes, moistens, non-adherent, bacteriostatic).
  • General regulatory information.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (for a PMA or a more recent 510(k) that might include performance data), or a full study report.

N/A