The following data is part of a premarket notification filed by Micrins Surgical, Inc. with the FDA for Micrins Contrast Background Material.
| Device ID | K933310 |
| 510k Number | K933310 |
| Device Name: | MICRINS CONTRAST BACKGROUND MATERIAL |
| Classification | Microscope, Surgical |
| Applicant | MICRINS SURGICAL, INC. 28438 BALLARD DR. Lake Forest, IL 60045 |
| Contact | Bernhard Teitz |
| Correspondent | Bernhard Teitz MICRINS SURGICAL, INC. 28438 BALLARD DR. Lake Forest, IL 60045 |
| Product Code | EPT |
| CFR Regulation Number | 878.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-07 |
| Decision Date | 1993-08-19 |