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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 6-302: ISO 9626 First edition 1991-09-01, stainless steel needle tubing for the manufacture of medical devices [including: amendment 1 (2001)]. (General Plastic Surgery/General Hospital)

Date of Standard: 1991. 
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:
Hypodermic Single Lumen Needles
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§880.5570 Needle, Hypodermic, Single Lumen Class 2 FMI
§880.5725 Pump, Infusion Class 2 FRN
FDA Technical Contact:
 William Burdick
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2522
  Silver Spring MD 20993
  301/796-6286
  email: william.burdick@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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