The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Portex Hypodermic Needle-pro Fixed Needle Syringe.
| Device ID | K063755 |
| 510k Number | K063755 |
| Device Name: | PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-19 |
| Decision Date | 2007-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10351688070241 | K063755 | 000 |
| 35019517065620 | K063755 | 000 |
| 55019517065617 | K063755 | 000 |
| 55019517065600 | K063755 | 000 |
| 35019517065590 | K063755 | 000 |
| 55019517065587 | K063755 | 000 |
| 35019517065576 | K063755 | 000 |
| 55019517065563 | K063755 | 000 |
| 35019517065552 | K063755 | 000 |
| 35019517065668 | K063755 | 000 |
| 30351688060833 | K063755 | 000 |
| 10351688070234 | K063755 | 000 |
| 10351688064509 | K063755 | 000 |
| 10351688064493 | K063755 | 000 |
| 10351688064486 | K063755 | 000 |
| 10351688060976 | K063755 | 000 |
| 30351688060963 | K063755 | 000 |
| 30351688060956 | K063755 | 000 |
| 10351688060945 | K063755 | 000 |
| 35019517065545 | K063755 | 000 |