The following data is part of a premarket notification filed by Sims Portex, Inc. with the FDA for Hypodermic Needle-pro Needle With Needle Protection Device; Hypodermic Needle-pro Syringe & Needle With Needle Protectio.
| Device ID | K011925 |
| 510k Number | K011925 |
| Device Name: | HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SIMS PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Brain D Farias |
| Correspondent | Brain D Farias SIMS PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-20 |
| Decision Date | 2001-07-12 |
| Summary: | summary |