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: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: K030774 , K030921 , K061227 , K081724 , K110318

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.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and are connected to a wavy line at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circle around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2007

George D. Petito, Ph.D. President The Hymed Group Corporation 1890 Bucknell Drive Bethlehem, Pennsylvania 18015

K955506 Re: Trade Name: HYCURE™ Regulatory Class: Unclassified Product Code: KGN Dated: December 22, 1995 Received: December 28, 1995

Dear Dr. Petito:

This letter corrects our substantially equivalent letter of January 17, 1996.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration and the following limitations:

1. This device may not be labeled for use on third degree burns.

2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.

3. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.

{1}------------------------------------------------

Page 2 - Dr. George D. Petito

4. This device may not be labeled as a treatment or a cure for any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not I carrer agencies: "100 mm 11sting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 110(k) premarket notification. The FDA finding of substantial equivalence of your device s rolly premainteted predicate device results in a classification for your device and thus, permits your device to proceed to the market.

{2}------------------------------------------------

Page 3 - Dr. George D. Petito

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. lelkersc Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Regulation Number and Section

N/A