The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Epidural Minifilter Luer 80369-7, Epidural Minifilter Nrfit 80369-6.
| Device ID | K190663 |
| 510k Number | K190663 |
| Device Name: | Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 |
| Classification | Filter, Conduction, Anesthetic |
| 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 | BSN |
| CFR Regulation Number | 868.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-15 |
| Decision Date | 2019-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048223041796 | K190663 | 000 |
| 04048223031315 | K190663 | 000 |