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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 030 FR Publication Date: 01/15/2013 

Part B: Supplementary Information

Recognition Number 6-122: ISO 8536-5 Second edition 2004-02-01, infusion equipment for medical use - part 5: burette infusion sets for single use, gravity feed. (General Plastic Surgery/General Hospital)

Date of Standard: 2004. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
CDRH Office and Division associated with recognized standards:
Devices Affected:
Burette Type Infusion Sets
Processes Affected:
510(k), IDE, PMA, PDP
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Device Name Device
§880.5440 Set, Administration, Intravascular Class 2 FPA
Relevant Guidance:
Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)] Document issued on: July 11, 2008
FDA Technical Contact:
 Keith Marin
  10903 New Hampshire Avenue Building 66, Room 2567
  Silver Spring MD 20993
  email: keith.marin@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