The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Portex Hypodermic Needle- Pro Edge Safety Device, 18gx1, 401810, 19gx1, 401910, 20gx1,402010, 21gx1402110.
| Device ID | K063450 |
| 510k Number | K063450 |
| Device Name: | PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110 |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Brian Farias |
| Correspondent | Brian Farias SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-15 |
| Decision Date | 2007-01-25 |
| Summary: | summary |