The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Sprotte Nrfit, Quincke Nrfit Lumbar Puncture Needles.
| Device ID | K160294 |
| 510k Number | K160294 |
| Device Name: | SPROTTE NRFit, Quincke NRFit Lumbar Puncture Needles |
| 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 | 2016-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048223028698 | K160294 | 000 |
| 04048223113820 | K160294 | 000 |