The following data is part of a premarket notification filed by Directed Energy, Inc. with the FDA for Model 20-c W/br-20a/u Attach/model Hl-3.0 Ob/gyn.
| Device ID | K870841 |
| 510k Number | K870841 |
| Device Name: | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN |
| 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 | 1987-02-26 |
| Decision Date | 1988-02-02 |