Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
021
|
Date of Entry 03/18/2009
|
FR Recognition Number
|
6-215
|
Standard | |
ASTM F2132-01 (Reapproved 2008)e1 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps |
|
Extent of Recognition
|
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§880.5570 |
Container, Sharps
|
Class 2
|
MMK
|
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers, Issued October 1993
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. |