BIOTIS COOKED MEAT

Culture Media, Enriched

OTISVILLE BIOTECH, INC.

The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Biotis Cooked Meat.

Pre-market Notification Details

Device IDK860410
510k NumberK860410
Device Name:BIOTIS COOKED MEAT
ClassificationCulture Media, Enriched
Applicant OTISVILLE BIOTECH, INC. P.O. BOX 567 Otisville ,  NY  10963 -
ContactErnest M Green
CorrespondentErnest M Green
OTISVILLE BIOTECH, INC. P.O. BOX 567 Otisville ,  NY  10963 -
Product CodeKZI  
CFR Regulation Number866.2330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-03
Decision Date1986-02-24

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