The following data is part of a premarket notification filed by Chester Labs, Inc. with the FDA for Statsign Electrode Conductivity Gel, Graham-field Electrode Conductivity Gel, Models 004008, 48-4000 2gf, 48-4000gf.
| Device ID | K001705 |
| 510k Number | K001705 |
| Device Name: | STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF |
| Classification | Media, Electroconductive |
| Applicant | CHESTER LABS, INC. 1900 SECTION RD., SUITE A Cincinnati, OH 45237 |
| Contact | Holly Sherwood |
| Correspondent | Holly Sherwood CHESTER LABS, INC. 1900 SECTION RD., SUITE A Cincinnati, OH 45237 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-05 |
| Decision Date | 2000-06-29 |