The following data is part of a premarket notification filed by Surgical Technology Laboratories, Inc with the FDA for Saf-t-vac Smoke And Fluid Evacuator.
| Device ID | K170582 |
| 510k Number | K170582 |
| Device Name: | Saf-T-Vac Smoke And Fluid Evacuator |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Surgical Technology Laboratories, Inc 1566 Whiting Way Lugoff, SC 29078 |
| Contact | Mathew Fairfax |
| Correspondent | Mathew Fairfax Surgical Technology Laboratories, Inc 1566 Whiting Way Lugoff, SC 29078 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-28 |
| Decision Date | 2017-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851988007983 | K170582 | 000 |
| B461JAU97971 | K170582 | 000 |