EARLOOP PROCEDURE MASK

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. FEB 2 0 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Medipack Medical Packaging Manufacturing Company C/O Mr. Antonio L. Giaccio, Director Regulatory & Quality Affairs Cypress Medical Products, LP 1202 South Route 31 McHenry, Illinois 60050 Re: K034015 Trade/Device Name: Earloop Procedure Mask Regulation Number: 878.4040 Regulation Name: Surgical Apparcl Regulatory Class: II Product Code: FXX Dated: February 2, 2004 Received: February 4, 2004 Dear Mr. Giaccio: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaller some is substantially cquivalent (for the itelevelocal above and have attennelosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Antichtinents, or to de roos and Cosmetic Act (Act) that do not require approval of a premarket the Fouchal I vou, Drag, and Counmay, therefore, market the device, subject to the general approval application (1 Mr ). - The general controls provisions of the Act include controls providents of the engistration, 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (FMA), it may of subject in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register. {1}------------------------------------------------ ## Page 2 - Mr. Giaccio Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA 3 issualles of a bassaanties with other requirements mean that FDA has made a decemination until Jour Journalisms administered by other Federal statistic of the Act of any Federal statutes and regurements, including, but not limited to: registration You must comply with an the 7et 3 roquitements art 801); good manufacturing practice and listing (21 CFR 1 at 607), laooling (21 CFR Part 820), and if 1 CFR Part 820), and if requirements as set form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manceans your alence of your device to a premarket notification. The PDF intelligence of color 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), If you desire specific advice for your device et (301) 594-4618_ Also, please note the regulation please contact inc Office or Comphanes are (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Bina8-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Applicant: Medipack Medical Packaging Mfg., Co Clo Antonio L. Giaccio 1202 S. Rte. 31 McHenry, IL 60050 510(k) Number (if known): K034015 Device Name: Earloop Procedure Mask ClassIfication Name: Surgical Mask Indications For Use: A Surgical Mask is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate materials. Susanna Faruto (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K03 4015 | Labels | Values | |---------------------------------------------|--------| | Prescription Use(Part 21 CFR 801 Subpart D) | | | Over-The-Counter Use(21 CFR 807 Subpart C) | ✓ | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of ____________________________________________________________________________________________________________________________________________________________________