LICEMEISTER COMB

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Public Health" on the first line and "Service" on the second line. The text appears to be part of a document or sign. Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 8 1998 Mr. Hans Schwartz ·Research Associate National Pediculosis Association, Incorporated 50 Kearney Road Needham, Massachusetts 02194 Re : K981250 LiceMeister™ Comb Trade Name: Regulatory Class: Unclassified Product Code: LJL Dated: March 30, 1998 Received: April 6, 1998 Dear Mr. Schwartz: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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. 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. র 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 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 {1}------------------------------------------------ Page 2 - Mr. Schwartz through 542 of the Act for devices under the Electronic enrough sadiation 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 regulation (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 ene rogalación Shoreiou) : Bianalig bj - 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, Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluațion Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Re. K981250 Indications For Use | <strong>Labels</strong> | <strong>Values</strong> | |--------------------------|-------------------------| | 510(k) Number (if known) | K981250 | | Device Name: | LICE MEISTER COMB | Indications For Us =: cleening DETECTION THEIR E of LICE (FLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescripcion Use OR Over-The-Counter Use (Optional Format 1-2-96) Paticia Cuenca (Division Sign-Off) Division of Demal. Infection Control, and General Hospital Devices 510(k) Number.