The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Binocular Oper. Microscopes & Accessor.
| Device ID | K822181 |
| 510k Number | K822181 |
| Device Name: | BINOCULAR OPER. MICROSCOPES & ACCESSOR |
| Classification | Microscope, Surgical, General & Plastic Surgery |
| Applicant | KELLEHER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FSO |
| CFR Regulation Number | 878.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-23 |
| Decision Date | 1982-08-27 |