The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Tissue Cassettes For Processing-em Bed.
Device ID | K831334 |
510k Number | K831334 |
Device Name: | TISSUE CASSETTES FOR PROCESSING-EM BED |
Classification | Cassettes, Tissue |
Applicant | SURGIPATH MEDICAL INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IDZ |
CFR Regulation Number | 864.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-25 |
Decision Date | 1983-05-25 |