The following data is part of a premarket notification filed by Persyst Development Corp. with the FDA for Presson Electrode.
| Device ID | K103103 |
| 510k Number | K103103 |
| Device Name: | PRESSON ELECTRODE |
| Classification | Electrode, Needle |
| Applicant | PERSYST DEVELOPMENT CORP. 3177 CLEARWATER DRIVE Prescott, AZ 86305 |
| Contact | Scott B Wilson |
| Correspondent | Scott B Wilson PERSYST DEVELOPMENT CORP. 3177 CLEARWATER DRIVE Prescott, AZ 86305 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-20 |
| Decision Date | 2011-12-08 |
| Summary: | summary |