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 |