The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Tuohy Nrfit.
| Device ID | K160297 |
| 510k Number | K160297 |
| Device Name: | Tuohy NRFit |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | PAJUNK GmbH Medizintechnologie Karl-Hall-Str. 1 Geisingen, DE 78187 |
| Contact | Christian G.h. Quass |
| Correspondent | Christian G.h. Quass PAJUNK GmbH Medizintechnologie Karl-Hall-Str. 1 Geisingen, DE 78187 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-03 |
| Decision Date | 2016-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14048223032296 | K160297 | 000 |
| 04048223032299 | K160297 | 000 |
| 04048223028759 | K160297 | 000 |
| 04048223036570 | K160297 | 000 |
| 04048223033906 | K160297 | 000 |
| 04048223113110 | K160297 | 000 |
| 04048223113103 | K160297 | 000 |
| 04048223113097 | K160297 | 000 |
| 04048223113080 | K160297 | 000 |
| 04048223113073 | K160297 | 000 |
| 04048223113066 | K160297 | 000 |
| 04048223113059 | K160297 | 000 |
| 04048223113042 | K160297 | 000 |
| 04048223028742 | K160297 | 000 |
| 04048223029831 | K160297 | 000 |
| 04048223029848 | K160297 | 000 |
| 14048223029852 | K160297 | 000 |
| 14048223029845 | K160297 | 000 |
| 14048223029838 | K160297 | 000 |
| 14048223029739 | K160297 | 000 |
| 14048223028756 | K160297 | 000 |
| 14048223028749 | K160297 | 000 |
| 14048223002831 | K160297 | 000 |
| 14048223036577 | K160297 | 000 |
| 14048223033903 | K160297 | 000 |
| 04048223002834 | K160297 | 000 |
| 04048223029732 | K160297 | 000 |
| 04048223029855 | K160297 | 000 |
| 04048223113035 | K160297 | 000 |