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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 K191885
Device Name Standard Bougie
Applicant
Standard Bariatrics
4362 Glendale Milford Rd.
Cincinnati,  OH  45242
Applicant Contact Alison Sathe
Correspondent
Standard Bariatrics
4362 Glendale Milford Rd.
Cincinnati,  OH  45242
Correspondent Contact Alison Sathe
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/15/2019
Decision Date 04/08/2020
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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