The following data is part of a premarket notification filed by Directed Energy, Inc. with the FDA for Model 20-c W/ar-10a/u Attach. For Arthro. Surgery.
| Device ID | K872711 |
| 510k Number | K872711 |
| Device Name: | MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-07 |
| Decision Date | 1987-09-28 |