Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-122: ISO 8536-5 Second edition 2004-02-01, Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed. (General Plastic Surgery/General Hospital)
Date of Standard: 2004. |
| 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 Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Burette Type Infusion Sets |
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| Processes Affected: |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5440 |
Set, Administration, Intravascular |
Class 2 |
FPA |
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| Relevant Guidance: |
| Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)] Document issued on: July 11, 2008 |
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| 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 |
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| * 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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