The following data is part of a premarket notification filed by Estech, Inc. with the FDA for Cobra Adhere Surgical System.
| Device ID | K041599 |
| 510k Number | K041599 |
| Device Name: | COBRA ADHERE SURGICAL SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ESTECH, INC. 1193 SHERMAN STREET Alameda, CA 94501 |
| Contact | Craig Coombs |
| Correspondent | Craig Coombs ESTECH, 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 | 2004-06-14 |
| Decision Date | 2004-07-27 |
| Summary: | summary |