The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Alcon Operating Microscopes.
| Device ID | K920641 |
| 510k Number | K920641 |
| Device Name: | ALCON OPERATING MICROSCOPES |
| Classification | Microscope, Operating & Accessories, Ac-powered, Ophthalmic |
| Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Contact | David Krapf |
| Correspondent | David Krapf ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Product Code | HRM |
| CFR Regulation Number | 878.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-12 |
| Decision Date | 1992-10-09 |