The following data is part of a premarket notification filed by Specialized Laboratory Equipment, Ltd. with the FDA for Sle Electrodes And Accessories.
| Device ID | K980410 |
| 510k Number | K980410 |
| Device Name: | SLE ELECTRODES AND ACCESSORIES |
| Classification | Electrode, Cutaneous |
| Applicant | SPECIALIZED LABORATORY EQUIPMENT, LTD. 3407 BAY AVE. Chico, CA 95973 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson SPECIALIZED LABORATORY EQUIPMENT, LTD. 3407 BAY AVE. Chico, CA 95973 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-03 |
| Decision Date | 1998-10-22 |
| Summary: | summary |