H292

Cells, Animal And Human, Cultured

BARTELS, INC.

The following data is part of a premarket notification filed by Bartels, Inc. with the FDA for H292.

Pre-market Notification Details

Device IDK942820
510k NumberK942820
Device Name:H292
ClassificationCells, Animal And Human, Cultured
Applicant BARTELS, INC. 2005 N.W. SAMMAMISH RD., #107 Issaquah,  WA  98027
ContactRebecca D Fuller
CorrespondentRebecca D Fuller
BARTELS, INC. 2005 N.W. SAMMAMISH RD., #107 Issaquah,  WA  98027
Product CodeKIR  
CFR Regulation Number864.2280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-15
Decision Date1995-05-05

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