The following data is part of a premarket notification filed by Exakt Medical Instruments, Inc. with the FDA for Exakt Cutting & Grinding System.
| Device ID | K883514 |
| 510k Number | K883514 |
| Device Name: | EXAKT CUTTING & GRINDING SYSTEM |
| Classification | Microtome, Cryostat |
| Applicant | EXAKT MEDICAL INSTRUMENTS, INC. 1000 S. MCKINLEY P.O.BOX 83343 OKLAHOMA CITY, OK 73148 |
| Contact | LINDA E DURBIN |
| Correspondent | LINDA E DURBIN EXAKT MEDICAL INSTRUMENTS, INC. 1000 S. MCKINLEY P.O.BOX 83343 OKLAHOMA CITY, OK 73148 |
| Product Code | IDP |
| CFR Regulation Number | 864.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-17 |
| Decision Date | 1988-08-29 |