(508 days)
Treatment for dermatologic disorders.
Not Found
This document is a 510(k) premarket notification approval letter from the FDA to MedFaxx, Inc. for their V-254 device. It indicates the device has been found substantially equivalent to a legally marketed predicate device.
Unfortunately, the provided text does not contain any information about the acceptance criteria, device performance, or any details about a study performed to establish substantial equivalence.
The text is purely an approval letter, stating that the device can be marketed. It references the 510(k) premarket notification submission where such details would typically be found, but those details are not present in this document.
Therefore, I cannot answer your specific questions as the required information is not available in the given input.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its body or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 1999
Mr. Bob Johnson Vice President MedFaxx, Inc. P.O. Box 17827 Raleigh, North Carolina 27619
Re: K973865 Trade Name: V-254 Regulatory Class: Unclassified Product Code: MXG Dated: November 30, 1998 Received: November 30, 1998
Dear Mr. Johnson:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave lovice your boomer be device is substantially equivalent (for the indications for above and we have docements alevices marketed in interstate commerce prior to use stated in the cheropent date of the Medical Device Amendments, or to devices that May 20, 1770, the enavance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costlicte Act (110). Tournal) , rail controls provisions of the Act include requirements for provisions or ation, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major (1 romance I Ipprovial), or device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Bob Johnson
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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2004
Page _ of _
510(k) Number (if known): K 38 ك Device Name: Indications For Use: bacterici tor ત્વ વ matologic disorders C Q4 the 14 Treatment f open a h tor the Qu d 0 4 4 4 6 600 WOUW
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
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Division of General Restorative Devices
| 510(k) Number | K973865 |
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Prescription Use (Per 21 CFR 801.
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.