The following data is part of a premarket notification filed by Tecno Instruments (pvt.) Ltd. with the FDA for Tecno Disposable Fingerswitch Pencil, Model 150-100.
| Device ID | K002257 |
| 510k Number | K002257 |
| Device Name: | TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | TECNO INSTRUMENTS (PVT.) LTD. 55 NORTHERN BLVD., SUITE 200 Great Neck,, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk TECNO INSTRUMENTS (PVT.) LTD. 55 NORTHERN BLVD., SUITE 200 Great Neck,, NY 11021 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-25 |
| Decision Date | 2000-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50649111005730 | K002257 | 000 |
| 00810026180552 | K002257 | 000 |
| 00810026180576 | K002257 | 000 |
| 00810026181177 | K002257 | 000 |
| 00810026181184 | K002257 | 000 |
| 00810026180842 | K002257 | 000 |
| 00810026181368 | K002257 | 000 |
| 08964000207000 | K002257 | 000 |
| 00815871020091 | K002257 | 000 |
| 40649111005634 | K002257 | 000 |
| 00810026180200 | K002257 | 000 |