The following data is part of a premarket notification filed by Feel Tech with the FDA for Disposable Hypodermic Needle.
| Device ID | K092831 |
| 510k Number | K092831 |
| Device Name: | DISPOSABLE HYPODERMIC NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | FEEL TECH 300 ATWOOD Pittsburgh, PA 15213 |
| Contact | Peter Chun |
| Correspondent | Peter Chun FEEL TECH 300 ATWOOD Pittsburgh, PA 15213 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-15 |
| Decision Date | 2010-01-14 |
| Summary: | summary |