SAF-T-SYRINGE- 0.5 AND 1ML/CC

{0}------------------------------------------------ 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Safety Medical International, Incorporated C/O Ms. Fran White Regulatory Consultant MDC Associates, LLC 163 Cabot Street Beverly, Massachusetts 01915 MAR 0 6 2007 Re: K063340 Trade/Device Name: Saf-T-Syringe 0.5mL and 1.0mL Syringe, Saf-T-Syringe 0.5mL and 1.0mL Allergy Syringe, Tuberculin Syringe, Saf-T-Syringe 0.5mL and 1.0mL Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: January 24, 2007 Received: January 25, 2007 Dear Ms. White: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 - Ms. White Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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 vour device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Sutte y. Michael DmD 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 510(k) Number (if known): K063340 Device Name: Saf-T-Syringe 0.5mL and 1.0mL Insulin Syringe Indications For Use: The Saf-T-Syringe is a sterile, single-use, disposable safety syringe with an auto-retracting needle is intended for injection of insulin subcutaneously. The retractable needle withdraws into plunger body after completion of injection and reduces the risk of accidental needle sticks injuries during use. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X (21 CFR 801 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 1 A 06-3340 SAF-T-Syringe AI Request EM2 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known):_K063340 Device Name: Saf-T-Syringe 0.5mL and 1.0mL Allergy Syringe, Tuberculin Syringe Indications For Use: The Saf-T-Syringe is a sterile, single-use, disposable, safety syringe with an auto-retracting needle and is intended for injection of allergy testing fluid and tuberculin. The retractable needle withdraws into plunger body after completion of injection and reduces the risk of accidental needle sticks injuries during use. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 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 1 Smchuid ms Division of Western Alaska, Department of Health, Infection Control, Dental Services March 6, 2016 {4}------------------------------------------------ ## Indications for Use ## 510(k) Number (if known):_K063340 Device Name:_Saf-T-Syringe 0.5mL and 1.0mL syringe Indications For Use: The Saf-T-Syringe is a sterile, single-use, disposable, safety syringe with an auto-retracting needle and is intended for withdrawal of fluids and injection of fluids below the surface of the skin. The retractable needle withdraws into plunger body after completion of injection and reduces the risk of accidental needle sticks injuries during use. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 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 1 Suette Michaud The State Barren Book Child Car K06 334