The following data is part of a premarket notification filed by Hidrex Gmbh with the FDA for Hidrex Psp1000.
| Device ID | K133033 |
| 510k Number | K133033 |
| Device Name: | HIDREX PSP1000 |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | HIDREX GMBH 2611 SHARK CIRCLE Texas City, TX 77591 |
| Contact | Stefanie D Bankston |
| Correspondent | Stefanie D Bankston HIDREX GMBH 2611 SHARK CIRCLE Texas City, TX 77591 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-26 |
| Decision Date | 2015-04-08 |
| Summary: | summary |