The following data is part of a premarket notification filed by Endoscopic Technologies, Inc. with the FDA for Estech Cobra Bipolar System.
| Device ID | K053100 |
| 510k Number | K053100 |
| Device Name: | ESTECH COBRA BIPOLAR SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ENDOSCOPIC TECHNOLOGIES, INC. 1193 SHERMAN STREET Alameda, CA 94501 |
| Contact | Craig Coombs |
| Correspondent | Craig Coombs ENDOSCOPIC TECHNOLOGIES, INC. 1193 SHERMAN STREET Alameda, CA 94501 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-03 |
| Decision Date | 2005-12-19 |
| Summary: | summary |