The following data is part of a premarket notification filed by Litex Manufacturing, Inc. with the FDA for Operating Room Light Handle Adapter.
| Device ID | K142386 |
| 510k Number | K142386 |
| Device Name: | Operating Room Light Handle Adapter |
| Classification | Light, Surgical, Accessories |
| Applicant | Litex Manufacturing, Inc. 1501 Sunshine Drive Glendale, CA 91208 |
| Contact | Noel Gharibian |
| Correspondent | Mike Hoftman ADVANCED MEDICAL INNOVATIONS 8741 Shirley Ave Northridge, CA 91324 |
| Product Code | FTA |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-27 |
| Decision Date | 2014-09-29 |
| Summary: | summary |