The following data is part of a premarket notification filed by Estech, Inc. with the FDA for Estech Cobra(r) Genesis Bipolar Clamp.
| Device ID | K133017 |
| 510k Number | K133017 |
| Device Name: | ESTECH COBRA(R) GENESIS BIPOLAR CLAMP |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ESTECH, INC. 2603 CAMINO RAMON, STE 100 San Ramon, CA 94583 |
| Contact | Tamer Ibrahim |
| Correspondent | Tamer Ibrahim ESTECH, INC. 2603 CAMINO RAMON, STE 100 San Ramon, CA 94583 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-26 |
| Decision Date | 2013-10-07 |
| Summary: | summary |