Recognition List Number: 021 Publication Date: 03/18/2009
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-215: ASTM F 2132 -01 (Reapproved 2008)e1, Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps. (General Plastic Surgery/General Hospital)
Date of Standard: 2008. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Sharps Dispoal Containers |
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| Processes Affected: |
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| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5570 |
Container, Sharps |
Class 2 |
MMK |
| |
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| Relevant Guidance: |
| Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers, Issued October 1993 |
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| FDA Technical Contact: |
| Elaine Mayhall, Ph.D. |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2612 |
| Silver Spring MD 20993 |
| 301/796-6301 |
| Email: elaine.mayhall@fda.hhs.gov |
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