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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 K210598
Device Name Pediatric Nasogastric Feeding Tubes - Single ENFit Port
Applicant
CAIR LGL
Parc Tertiaire De Bois Dieu, 1 Allee Des Chevreuils
Lissieu,  FR 69380
Applicant Contact Irving L. Wiesen
Correspondent
Vesco Medical
1039 Kingsmill Parkway
Columbus,  OH  43229
Correspondent Contact Glenn Brunner
Regulation Number876.5980
Classification Product Code
PIF  
Date Received03/01/2021
Decision Date 11/02/2021
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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