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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 029 FR Publication Date: 08/20/2012 

Part B: Supplementary Information

Recognition Number 6-242: ISO 8536-2 Third edition 2010-03-15, infusion equipment for medical use - part 2: closures for infusion bottles. (General Plastic Surgery/General Hospital)

Date of Standard: 2009. 
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:
Closures for Infusion Bottles
Processes Affected:
510(k), PMA, IDE, PreIDE, PDP
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§880.5440 Set, I.V. Fluid Transfer Class 2 LHI
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
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2567
  Silver Spring MD 20993
  301/796-2462
  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
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