The following data is part of a premarket notification filed by The Hilrad Co. with the FDA for Steri-vers.
Device ID | K810311 |
510k Number | K810311 |
Device Name: | STERI-VERS |
Classification | Device, Pasteurization, Hot Water |
Applicant | THE HILRAD CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LDS |
CFR Regulation Number | 880.6991 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-02-05 |
Decision Date | 1981-04-17 |