RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR

Indicator, Biological Sterilization Process

RAVEN BIOLOGICAL LABORATORIES, INC.

The following data is part of a premarket notification filed by Raven Biological Laboratories, Inc. with the FDA for Raven Protest - Steam Biological Indicator.

Pre-market Notification Details

Device IDK082756
510k NumberK082756
Device Name:RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR
ClassificationIndicator, Biological Sterilization Process
Applicant RAVEN BIOLOGICAL LABORATORIES, INC. 8607 PARK DR. Omaha,  NE  68127
ContactWendy Royalty-hann
CorrespondentWendy Royalty-hann
RAVEN BIOLOGICAL LABORATORIES, INC. 8607 PARK DR. Omaha,  NE  68127
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-19
Decision Date2009-10-21
Summary:summary

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