DRAGON HEART PISTON SYRINGE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC - 1 2004 Dragon Heart Medical Device Company Limited C/O Ms. Jina Yu President Dragon Heart Medical, Incorporated 188 Industrial Drive, Suite 108 Elmhurst, Illinois 60126 Re: K042547 Trade/Device Name: Dragon Heart Piston Syringe Regulation Number: Piston Syringe Regulation Name: 880.5860 Regulatory Class: II Product Code: FMF Dated: September 15, 2004 Received: September 20, 2004 Dear Ms. Yu: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becales been be is substantially equivalent (for the relerenced above and nave determined are to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale conmisee pror to that have been reclassified in accordance with the provisions of Amendinents, or to devroos that have a act (Act) that do not require approval of a premarket the rederal I vou, Drug, und Commons , therefore, market the device, subject to the general approval appreation (1171). The general controls provisions of the Act include Controls provisions of the vistration, 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 If your device is chasined (see as over additional controls. Existing major regulations affecting ( (FMA), it may be subject to have adam f Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Sous nouncements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 - Ms. Yu Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled or a bases on plies with other requirements meall that IDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal statues and regaratents, including, but not limited to: registration You music colliply with an the Fect 5 requirements (art 801); good manufacturing practice and listing (21 CFK Pat 807), laooling (21 CFR Pat 820); and if and 820); and if requirements as set forth 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) I his letter will anow you to begin malicomig your ence of your device to a premarket notification. The PDF maining or obsision 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), If you desire specific advice to: your de at (240) 276-0115. Also, please note the regulation in please contact the Office or Comphanes are (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general mionnation in the mational and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Anthony D. Watson for Charles R. Byrd 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}------------------------------------------------ Dragon Heart Medical Device Co., Ltd. 510(k) Piston syringes Submission Application ## Statement of Indications for Use 510(k) Number : Device Name: Dragon Heart Piston Syringe Intended Use: The Dragon Heart Piston Syringe is design for medical purposes to inject fluids into or withdraw fluids from the body. The syringe has a graduated barrel, a plunger, a hub and a needle. Prescription Use v (Part 21 CFR 801 Subpart D) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ and/or (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) Anthen D. m (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: JEPY 2547 Dragonheart Ver: 1/0 Page 6 of 33