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 |