The following data is part of a premarket notification filed by Adel Medical Ltd. with the FDA for Minor Surgery Light Model 2112.
| Device ID | K860020 |
| 510k Number | K860020 |
| Device Name: | MINOR SURGERY LIGHT MODEL 2112 |
| Classification | Light, Surgical, Floor Standing |
| Applicant | ADEL MEDICAL LTD. 16700 S.E. 120TH AVE. P.O. BOX 542 Clackamas, OR 97015 |
| Contact | Dave Cole |
| Correspondent | Dave Cole ADEL MEDICAL LTD. 16700 S.E. 120TH AVE. P.O. BOX 542 Clackamas, OR 97015 |
| Product Code | FSS |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-03 |
| Decision Date | 1986-01-24 |