The following data is part of a premarket notification filed by Thermolyne Corp. with the FDA for Histo-center Ii.
Device ID | K792095 |
510k Number | K792095 |
Device Name: | HISTO-CENTER II |
Classification | Dispensers, Paraffin |
Applicant | THERMOLYNE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IDW |
CFR Regulation Number | 864.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-17 |
Decision Date | 1979-11-20 |