The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Travaspore Biological Indicator.
Device ID | K832922 |
510k Number | K832922 |
Device Name: | TRAVASPORE BIOLOGICAL INDICATOR |
Classification | Indicator, Biological Sterilization Process |
Applicant | TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRC |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-24 |
Decision Date | 1983-11-21 |