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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Tubes With Enteral Specific Connectors
510(k) Number K250481
Device Name Extension Feeding Set with ENFit™ Connectors
Applicant
SKY Medical, a.s.
Vicenzy 24/2058
Samorin,  SK 931 01
Applicant Contact Yulia Surinova
Correspondent
SKY Medical, a.s.
Vicenzy 24/2058
Samorin,  SK 931 01
Correspondent Contact Yulia Surinova
Regulation Number876.5980
Classification Product Code
PIF  
Date Received02/19/2025
Decision Date 04/18/2025
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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