The following data is part of a premarket notification filed by Chester Labs, Inc. with the FDA for Modification To Statsign Saline Electrolyte Gel, Graham-field Saline Electrolyte Gel.
| Device ID | K001593 |
| 510k Number | K001593 |
| Device Name: | MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-23 |
| Decision Date | 2000-06-14 |