The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Nagashima F60mm Attach. Lens.
Device ID | K821705 |
510k Number | K821705 |
Device Name: | NAGASHIMA F60MM ATTACH. LENS |
Classification | Lens, Camera, Surgical |
Applicant | KELLEHER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FXQ |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-09 |
Decision Date | 1982-07-09 |