The following data is part of a premarket notification filed by Waismed Ltd. with the FDA for Nio-p.
| Device ID | K160805 |
| 510k Number | K160805 |
| Device Name: | NIO-P |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | WAISMED LTD. 10 AMAL ST. AFEK INDUSTRIAL PARK, Rosh Ha'ayin, IL 4809234 |
| Contact | Einat Swisa |
| Correspondent | Jonathan S. Kahan HOGAN LOVELLS US LLP COLUMBIA SQUARE, 555 THIRTEENTH ST 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 | 2016-03-23 |
| Decision Date | 2016-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290008325025 | K160805 | 000 |
| 07290008325080 | K160805 | 000 |