The following data is part of a premarket notification filed by Nanopass Technologies Ltd. with the FDA for Micronjet 600.
| Device ID | K092746 |
| 510k Number | K092746 |
| Device Name: | MICRONJET 600 |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | NANOPASS TECHNOLOGIES LTD. 555 13TH ST. NW Washington, DC 20004 |
| Contact | Jonathan Kahan |
| Correspondent | Jonathan Kahan NANOPASS TECHNOLOGIES LTD. 555 13TH ST. NW Washington, DC 20004 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-08 |
| Decision Date | 2010-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290015928080 | K092746 | 000 |
| 17290015928035 | K092746 | 000 |
| 17290015928011 | K092746 | 000 |
| 17290015928226 | K092746 | 000 |
| 17290015928271 | K092746 | 000 |
| 17290015928257 | K092746 | 000 |