The following data is part of a premarket notification filed by Tecno Instruments (pvt.) Ltd. with the FDA for Tecno Reusable Bipolar Cables, Model 190-100 And 190-110.
| Device ID | K042608 |
| 510k Number | K042608 |
| Device Name: | TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | TECNO INSTRUMENTS (PVT.) LTD. 55 NORTHERN BLVD., SUITE 200 Great Neck,, NY 11021 |
| Contact | Mohan Ratanchandani |
| Correspondent | Mohan Ratanchandani 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 | 2004-09-24 |
| Decision Date | 2004-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08964001339007 | K042608 | 000 |
| 00810026180538 | K042608 | 000 |
| 00810026180521 | K042608 | 000 |