The following data is part of a premarket notification filed by Seltrex, Corp. with the FDA for Cromic Surgical Microscope Model Mc-1.
| Device ID | K852586 |
| 510k Number | K852586 |
| Device Name: | CROMIC SURGICAL MICROSCOPE MODEL MC-1 |
| Classification | Microscope, Operating & Accessories, Ac-powered, Ophthalmic |
| Applicant | SELTREX, CORP. 450 SAN ANTONIO RD., STE. 33 Palo Alto, CA 94306 |
| Contact | Di Tomas |
| Correspondent | Di Tomas SELTREX, CORP. 450 SAN ANTONIO RD., STE. 33 Palo Alto, CA 94306 |
| Product Code | HRM |
| CFR Regulation Number | 878.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-18 |
| Decision Date | 1985-07-30 |