Standard Bougie, 38 Fr. And Hand Pump

Tubes, Gastrointestinal (and Accessories)

Standard Bariatrics

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

Pre-market Notification Details

Device IDK212728
510k NumberK212728
Device Name:Standard Bougie, 38 Fr. And Hand Pump
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant Standard Bariatrics 4362 Glendale Milford Rd. Cincinnati,  OH  45242
ContactMichelle Schnell
CorrespondentMichelle Schnell
Standard Bariatrics 4362 Glendale Milford Rd. Cincinnati,  OH  45242
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-27
Decision Date2021-09-23

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