The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Lifecare Electrodes.
Device ID | K083302 |
510k Number | K083302 |
Device Name: | LIFECARE ELECTRODES |
Classification | Electrode, Cutaneous |
Applicant | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 845 ARONSON LAKE COURT Roswell, GA 30075 |
Contact | Jay Mansour |
Correspondent | Jay Mansour EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 845 ARONSON LAKE COURT Roswell, GA 30075 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-11-10 |
Decision Date | 2009-08-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30816924020120 | K083302 | 000 |
30816924020083 | K083302 | 000 |
30816924020076 | K083302 | 000 |
20816924020062 | K083302 | 000 |
20816924020048 | K083302 | 000 |