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 |