Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
031
|
Date of Entry 08/06/2013
|
FR Recognition Number
|
6-240
|
Standard | |
ISO 8536-3 Third edition 2009-06-01 Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles |
|
Extent of Recognition
|
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§880.5440 |
Set, I.V. Fluid Transfer
|
Class 2
|
LHI
|
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)] Document issued on: July 11, 2008
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
FDA Technical Contact
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital |
|
*These are provided as examples and others may be applicable. |