The following data is part of a premarket notification filed by Precision Surgical, Llc with the FDA for Cut-vac Lighted Smoke Evacuation Electrosurgical Pencil.
| Device ID | K170721 |
| 510k Number | K170721 |
| Device Name: | Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Precision Surgical, LLC 245 E Warm Springs Rd, #132 Las Vegas, NV 89119 |
| Contact | Prash Jayaraj |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-03-09 |
| Decision Date | 2017-04-21 |
| Summary: | summary |