The following data is part of a premarket notification filed by Ace Medical Devices Pvt. Ltd. with the FDA for Ace Electrosurgical Resection And Vaporization Electrodes Series.
| Device ID | K153055 |
| 510k Number | K153055 |
| Device Name: | ACE Electrosurgical Resection And Vaporization Electrodes Series |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Ace Medical Devices Pvt. Ltd. E-1/7, Neptune Society Kalyani Nagar Pune, IN 411006 |
| Contact | Vikas Sethi |
| Correspondent | Traves Brady Pacific Surgical Specialties, LLC 428 W 21st Ave Spokane, WA 99203 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-20 |
| Decision Date | 2016-07-11 |
| Summary: | summary |