TRAVASPORE BIOLOGICAL INDICATOR

Indicator, Biological Sterilization Process

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Travaspore Biological Indicator.

Pre-market Notification Details

Device IDK832922
510k NumberK832922
Device Name:TRAVASPORE BIOLOGICAL INDICATOR
ClassificationIndicator, Biological Sterilization Process
Applicant TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-08-24
Decision Date1983-11-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.