The following data is part of a premarket notification filed by Tone-a-matic International Inc. with the FDA for Conductive Gel.
| Device ID | K221724 |
| 510k Number | K221724 |
| Device Name: | Conductive Gel |
| Classification | Media, Electroconductive |
| Applicant | Tone-A-Matic International Inc. 145 Traders East Unit 18 Mississauga, CA L5Z-3L3 |
| Contact | Manuel Chuck |
| Correspondent | Manuel Chuck Tone-A-Matic International Inc. 145 Traders East Unit 18 Mississauga, CA L5Z-3L3 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-14 |
| Decision Date | 2022-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06278437251454 | K221724 | 000 |