Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-293: ISO 23907 First edition 2012-09-01, Sharps injury protection - Requirements and test methods - Sharps containers. (General Plastic Surgery/General Hospital)
Date of Standard: 2012. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | DIV OF ANESTHESIOLOGY,GEN. HOSPITAL, INFECTION CONTROL & DENTAL DEVICE (DAGRID) |
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| (2) | OFFICE OF COMPLIANCE (OC) |
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| Devices Affected: |
| Sharps Disposal Containers |
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| Processes Affected: |
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| Type of Standard: |
| Vertical, National |
| Extent of Recognition: |
| Complete standard and any annexes |
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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 Ootober 1993 |
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| FDA Technical Contacts: |
| 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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| Matthew Schwerin |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 2216 |
| Silver Spring MD 20993 |
| 301/563-9114 |
| Email: matthew.schwerin@fda.hhs.gov |
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