The following data is part of a premarket notification filed by Portex, Inc. with the FDA for Hypodermic Needle-pro Insulin Syrine & Needle With Needle Protection Device.
| Device ID | K014073 |
| 510k Number | K014073 |
| Device Name: | HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE |
| Classification | Syringe, Piston |
| Applicant | PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Brain E Farias |
| Correspondent | Brain E Farias PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-10 |
| Decision Date | 2002-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10351688052049 | K014073 | 000 |
| 30351688052036 | K014073 | 000 |