The following data is part of a premarket notification filed by Nikon Inc. with the FDA for Aml (angle Magnifying Lens.
Device ID | K823719 |
510k Number | K823719 |
Device Name: | AML (ANGLE MAGNIFYING LENS |
Classification | Camera, Ophthalmic, Ac-powered |
Applicant | NIKON INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HKI |
CFR Regulation Number | 886.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-10 |
Decision Date | 1983-01-05 |