The following data is part of a premarket notification filed by Stellartech Research Corp. with the FDA for Stellartech Coagulation System 2, Models 1100c-115a And 1100c-230a.
| Device ID | K050831 |
| 510k Number | K050831 |
| Device Name: | STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | STELLARTECH RESEARCH CORP. 1346 BORDEAUX DR. Sunnyvale, CA 94089 |
| Contact | James Santos |
| Correspondent | James Santos STELLARTECH RESEARCH CORP. 1346 BORDEAUX DR. Sunnyvale, CA 94089 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-01 |
| Decision Date | 2005-04-12 |
| Summary: | summary |