The following data is part of a premarket notification filed by Stellartech Research Corp. with the FDA for Stellartech 100 Coagulation System.
| Device ID | K061544 |
| 510k Number | K061544 |
| Device Name: | STELLARTECH 100 COAGULATION SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | STELLARTECH RESEARCH CORP. 1350 BORDEAUX DRIVE Sunnyvale, CA 94089 |
| Contact | James R Santos |
| Correspondent | James R Santos STELLARTECH RESEARCH CORP. 1350 BORDEAUX DRIVE Sunnyvale, CA 94089 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-05 |
| Decision Date | 2006-10-13 |
| Summary: | summary |