The following data is part of a premarket notification filed by Prevo Micro-mat System with the FDA for Micro-mat System.
| Device ID | K854121 |
| 510k Number | K854121 |
| Device Name: | MICRO-MAT SYSTEM |
| Classification | Spinner, Slide, Automated |
| Applicant | PREVO MICRO-MAT SYSTEM P.O. BOX 902 HIGHLAND, NY 12528 |
| Contact | ROBERT K MCEWEN |
| Correspondent | ROBERT K MCEWEN PREVO MICRO-MAT SYSTEM P.O. BOX 902 HIGHLAND, NY 12528 |
| Product Code | GKJ |
| CFR Regulation Number | 864.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-09 |
| Decision Date | 1985-10-31 |