The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Tissue Processing Cassettes & Access.
Device ID | K813430 |
510k Number | K813430 |
Device Name: | TISSUE PROCESSING CASSETTES & ACCESS |
Classification | Microtome, Accessories |
Applicant | AMERICAN OPTICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IDL |
CFR Regulation Number | 864.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-12-08 |
Decision Date | 1981-12-29 |