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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K210437
Device Name Standard Bougie, 38 Fr.
Applicant
Standard Bariatrics
4362 Glendale Milford Rd.
Cincinnati,  OH  45242
Applicant Contact Michelle Schnell
Correspondent
Standard Bariatrics
4362 Glendale Milford Rd.
Cincinnati,  OH  45242
Correspondent Contact Michelle Schnell
Regulation Number876.5980
Classification Product Code
KNT  
Date Received02/12/2021
Decision Date 06/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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