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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 6-179: ISO 21649 First edition 2006-06-01, needle-free injectors for medical use -- requirements and test methods. (General Plastic Surgery/General Hospital)

Date of Standard: 2006. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Needle-free injectors
Processes Affected:
510(k), PMA, IDE, PDP, HDE
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§880.5430 Injector, Fluid, Non-Electrically Powered Class 2 KZE
Relevant Guidance:
Guidance on the Content of Premarket Notification {510(k)} Submissions for Piston Syringes, Issued April 1993
FDA Technical Contact:
 Jacqueline Ryan, M.D.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2556
  Silver Spring MD 20993
  301/796-9599
  email: jacqueline.ryan@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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