The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Binocular Operating Microscopes &.
Device ID | K822012 |
510k Number | K822012 |
Device Name: | BINOCULAR OPERATING MICROSCOPES & |
Classification | Chair, Neurosurgical |
Applicant | KELLEHER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HBN |
CFR Regulation Number | 882.4125 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-08 |
Decision Date | 1982-07-30 |