The following data is part of a premarket notification filed by Phakosystems, Inc. with the FDA for Phakosystems Ct-100 Cautery Module.
| Device ID | K860236 |
| 510k Number | K860236 |
| Device Name: | PHAKOSYSTEMS CT-100 CAUTERY MODULE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | PHAKOSYSTEMS, INC. 490 CHAMPAGNE DR. Downsview M3j 2t9, CA |
| Contact | Keith L Carter |
| Correspondent | Keith L Carter PHAKOSYSTEMS, INC. 490 CHAMPAGNE DR. Downsview M3j 2t9, CA |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-23 |
| Decision Date | 1986-02-19 |