The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Spinal Manometer Nrfit; Spinal Manometer Luer.
| Device ID | K170305 |
| 510k Number | K170305 |
| Device Name: | Spinal Manometer NRFit; Spinal Manometer LUER |
| Classification | Manometer, Spinal-fluid |
| 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 | FMJ |
| CFR Regulation Number | 880.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-31 |
| Decision Date | 2017-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048223029770 | K170305 | 000 |
| 04048223022566 | K170305 | 000 |