The following data is part of a premarket notification filed by Ncontact Surgical, Inc. with the FDA for Ncontact Coagulation System Kit.
| Device ID | K062539 |
| 510k Number | K062539 |
| Device Name: | NCONTACT COAGULATION SYSTEM KIT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NCONTACT SURGICAL, INC. 2880 SLATER ROAD SUITE 103 Morrisville, NC 27560 |
| Contact | Jane Ricupero |
| Correspondent | Jane Ricupero NCONTACT SURGICAL, INC. 2880 SLATER ROAD SUITE 103 Morrisville, NC 27560 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-29 |
| Decision Date | 2006-12-01 |
| Summary: | summary |