The following data is part of a premarket notification filed by Electro-cap Intl., Inc. with the FDA for Electro-gel.
| Device ID | K111717 |
| 510k Number | K111717 |
| Device Name: | ELECTRO-GEL |
| Classification | Media, Electroconductive |
| Applicant | ELECTRO-CAP INTL., INC. 1011 WEST LEXINGTON RD. Eaton, OH 45320 |
| Contact | Amy B Swallows |
| Correspondent | Amy B Swallows ELECTRO-CAP INTL., INC. 1011 WEST LEXINGTON RD. Eaton, OH 45320 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-20 |
| Decision Date | 2012-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811478011920 | K111717 | 000 |
| 00811478011913 | K111717 | 000 |
| 00811478011906 | K111717 | 000 |
| 00811478011890 | K111717 | 000 |
| 00811478011883 | K111717 | 000 |