The following data is part of a premarket notification filed by Marco Ophthalmic, Inc. with the FDA for Marco Surgiscope Operation Microscopes.
| Device ID | K930439 |
| 510k Number | K930439 |
| Device Name: | MARCO SURGISCOPE OPERATION MICROSCOPES |
| Classification | Microscope, Operating & Accessories, Ac-powered, Ophthalmic |
| Applicant | MARCO OPHTHALMIC, INC. 11825 CENTRAL PKWY. Jacksonville, FL 32224 |
| Contact | Wayne Staring |
| Correspondent | Wayne Staring MARCO OPHTHALMIC, INC. 11825 CENTRAL PKWY. Jacksonville, FL 32224 |
| Product Code | HRM |
| CFR Regulation Number | 878.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-26 |
| Decision Date | 1993-07-22 |