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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 K241169
Device Name Entarik NI Feeding Tube System
Applicant
Gravitas Medical, Inc.
2332 Fourth St.
Suite E
Berkeley,  CA  94710
Applicant Contact Saheel Sutaria
Correspondent
Rqm+
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Lucie Dalet
Regulation Number876.5980
Classification Product Code
KNT  
Subsequent Product Code
FPD  
Date Received04/26/2024
Decision Date 11/22/2024
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
Predetermined Change
Control Plan Authorized		 No
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