Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-289: USP 35-NF30 <11>:2012, Sterile Water for Irrigation. (General Plastic Surgery/General Hospital)
Date of Standard: 2012. |
| Address of Standards Organization: |
| United States Pharmacopeial Convention, Inc. (USP) |
| 12601 Twinbrook Parkway |
| Rockville, MD 20852 |
| |
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
|
|
| Devices Affected: |
| Suction catheters and tips, connecting aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing |
|
| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE |
|
| Type of Standard: |
| National, Horizontal |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.6740 |
Catheter And Tip, Suction |
Class 2 |
JOL |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| 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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