Standard Tapered Bougie, 38 Fr.

Tubes, Gastrointestinal (and Accessories)

Standard Bariatrics, Inc.

The following data is part of a premarket notification filed by Standard Bariatrics, Inc. with the FDA for Standard Tapered Bougie, 38 Fr..

Pre-market Notification Details

Device IDK222085
510k NumberK222085
Device Name:Standard Tapered Bougie, 38 Fr.
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant Standard Bariatrics, Inc. 4362 Glendale Milford Road Cincinnati,  OH  45242
ContactMichelle Schnell
CorrespondentMichelle Schnell
Standard Bariatrics, Inc. 4362 Glendale Milford Road Cincinnati,  OH  45242
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-15
Decision Date2022-10-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10851677007123 K222085 000
00851677007171 K222085 000

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