HYCURE

• K Number: K955506
• Device Name: HYCURE
• Manufacturer: THE HYMED GROUP CORP.
• Date Cleared: 1996-01-17 ( 47 days)
• Product Code: KGN
• Regulation Number: N/A
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

(for the indications for use stated in the enclosure)

Device Description

Not Found

AI/ML Overview

This document is a marketing clearance letter from the FDA for the HYCURE™ device, a wound dressing. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The letter only states that the device is substantially equivalent to legally marketed predicate devices and outlines limitations on labeling claims.

Regulation Number and Section

N/A