The following data is part of a premarket notification filed by Dermatologic Lab & Supply, Inc. with the FDA for Electricator Model 26000.
| Device ID | K010025 |
| 510k Number | K010025 |
| Device Name: | ELECTRICATOR MODEL 26000 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DERMATOLOGIC LAB & SUPPLY, INC. 608 13TH AVE. Council Bluffs, IA 51501 |
| Contact | Deborah Grafelman |
| Correspondent | Deborah Grafelman DERMATOLOGIC LAB & SUPPLY, INC. 608 13TH AVE. Council Bluffs, IA 51501 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-03 |
| Decision Date | 2001-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00609960001234 | K010025 | 000 |
| 00609960001227 | K010025 | 000 |
| 00609960001210 | K010025 | 000 |
| 00609960001159 | K010025 | 000 |
| 00609960001142 | K010025 | 000 |