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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enteral Syringes With Enteral Specific Connectors
510(k) Number K231300
Device Name Nutricair Enteral Syringe with ENFit
Applicant
Cair Lgl
1, Allée Des Chevreuls
Lissieu,  FR 69380
Applicant Contact Irving L. Wiesen, Esq.
Correspondent
Cair Lgl
1, Allée Des Chevreuls
Lissieu,  FR 69380
Correspondent Contact Irving L. Wiesen, Esq.
Regulation Number876.5980
Classification Product Code
PNR  
Date Received05/04/2023
Decision Date 10/06/2023
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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