The following data is part of a premarket notification filed by Eswallow Usa with the FDA for Eswallow Usa Electrode,eswallow Usa Leadwire.
| Device ID | K113375 |
| 510k Number | K113375 |
| Device Name: | ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE |
| Classification | Electrode, Cutaneous |
| Applicant | ESWALLOW USA 3477 CREEK CIRCLE Guntersville, AL 35976 |
| Contact | William Ingram |
| Correspondent | William Ingram ESWALLOW USA 3477 CREEK CIRCLE Guntersville, AL 35976 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-16 |
| Decision Date | 2013-01-25 |
| Summary: | summary |