The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Pajunk Multistim Sensor Nerve Stimulators.
| Device ID | K061172 |
| 510k Number | K061172 |
| Device Name: | PAJUNK MULTISTIM SENSOR NERVE STIMULATORS |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | PAJUNK GMBH MEDIZINTECHNOLOGIE 106 EAST 5TH AVENUE Mount Dora, FL 32757 |
| Contact | Lynette L Howard |
| Correspondent | Lynette L Howard PAJUNK GMBH MEDIZINTECHNOLOGIE 106 EAST 5TH AVENUE Mount Dora, FL 32757 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-27 |
| Decision Date | 2006-10-17 |
| Summary: | summary |