The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Tissue-tek Iii Accu-cut Rotary Microtome.
| Device ID | K812558 |
| 510k Number | K812558 |
| Device Name: | TISSUE-TEK III ACCU-CUT ROTARY MICROTOME |
| Classification | Microtome, Rotary |
| Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IDO |
| CFR Regulation Number | 864.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-08 |
| Decision Date | 1981-09-29 |