The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Rotary Microtome.
| Device ID | K863548 |
| 510k Number | K863548 |
| Device Name: | ROTARY MICROTOME |
| Classification | Microtome, Rotary |
| Applicant | SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
| Contact | Urban, Ht(ascp) |
| Correspondent | Urban, Ht(ascp) SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
| Product Code | IDO |
| CFR Regulation Number | 864.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-12 |
| Decision Date | 1986-09-19 |