The following data is part of a premarket notification filed by Directed Energy, Inc. with the FDA for Surgical Carbon Dioxide Sys. Model 10-c Ob-gyn Use.
| Device ID | K862861 |
| 510k Number | K862861 |
| Device Name: | SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE |
| Classification | Laser, Surgical, Gynecologic |
| Applicant | DIRECTED ENERGY, INC. 11661 SAN VICENTE BLVD. SUITE 203 Los Angeles, CA 90049 |
| Contact | Edward Johansen |
| Correspondent | Edward Johansen DIRECTED ENERGY, INC. 11661 SAN VICENTE BLVD. SUITE 203 Los Angeles, CA 90049 |
| Product Code | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-29 |
| Decision Date | 1986-10-27 |