ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image contains the words "Public Health Service" in bold black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign. Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 1 0 2001 Asia-Med GMBH and CO KG C/O Mr. Kevin Walls Consultant Regulatory Insight Incorporated 13 Red Fox Lane Littleton, Colorado 80127 Re : K011808 Asia-Med Acupuncture Needles, Trade/Device Name: (Standard, Special, Compact, Apex) 880.5580 Requlation Number: II Requlatory Class: Product Code: MOX Dated: June 8, 2001 Received: June 11, 2001 Dear Mr. Walls: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market the device force resultable (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 ene enacement aue been reclassified in accordance with the devices that have book il Food, Drug, and Cosmetic Act (Act). 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 provision, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 {1}------------------------------------------------ Page 2 - Mr. Walls In addition, FDA may publish further announcements action. 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 requlations. 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21CFR 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/dsma/dsmamain.html". Sincerely yours, Timot y A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ \$\qquad K_{011}808\$ Page 1 of 1 510(k) Number (if known): asia-med acupuncture needles (Special, Standard, Compact and Device Name: Apex) for single use. Indications for Use: The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) B. Brilens Division Sign-C Division of Dental Inte 510(k) Number Prescription Use × (Per 21 CFR 801.109)