The following data is part of a premarket notification filed by Oximetrix, Inc. with the FDA for Hemo Static/esu Scalpel System.
| Device ID | K842622 |
| 510k Number | K842622 |
| Device Name: | HEMO STATIC/ESU SCALPEL SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | OXIMETRIX, INC. 1212 TERRA BELLA AVE. Mountain View, CA 94043 |
| Contact | Michael J Billig |
| Correspondent | Michael J Billig OXIMETRIX, INC. 1212 TERRA BELLA AVE. Mountain View, CA 94043 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-05 |
| Decision Date | 1984-10-23 |