The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Portex Needle-pro Edge Safety With Syringe, Models 432310, 432210, 432510, 432558.
| Device ID | K061194 |
| 510k Number | K061194 |
| Device Name: | PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558 |
| Classification | Syringe, Antistick |
| 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 | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-28 |
| Decision Date | 2006-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30351688069362 | K061194 | 000 |
| 55019517065877 | K061194 | 000 |
| 35019517065897 | K061194 | 000 |
| 35019517065903 | K061194 | 000 |
| 35019517065910 | K061194 | 000 |
| 35019517065934 | K061194 | 000 |
| 10351688075383 | K061194 | 000 |
| 30351688069331 | K061194 | 000 |
| 10351688069344 | K061194 | 000 |
| 10351688069351 | K061194 | 000 |
| 30351688075479 | K061194 | 000 |