The following data is part of a premarket notification filed by Gemore Technology Co., Ltd. with the FDA for Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series And Double Side Series.
| Device ID | K062675 |
| 510k Number | K062675 |
| Device Name: | GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES |
| Classification | Electrode, Cutaneous |
| Applicant | GEMORE TECHNOLOGY CO., LTD. 11 FL, NO. 29-5, SEC. 2 CHUNG CHENG E. RD. Tan Shui, Taipei Hsien, TW 251 |
| Contact | Tony C.s. Chang |
| Correspondent | Tony C.s. Chang GEMORE TECHNOLOGY CO., LTD. 11 FL, NO. 29-5, SEC. 2 CHUNG CHENG E. RD. Tan Shui, Taipei Hsien, TW 251 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-08 |
| Decision Date | 2007-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20665973017116 | K062675 | 000 |
| 20665973016812 | K062675 | 000 |