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FDA 510(k) Application Details - K231300
Device Classification Name
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510(K) Number
K231300
Device Name
Nutricair Enteral Syringe with ENFit
Applicant
Cair LG
1, AllΘe des Chevreuls
Lissieu 69380 FR
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Contact
Irving L. Wiesen, Esq.
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Regulation Number
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Classification Product Code
PNR
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Date Received
05/04/2023
Decision Date
10/06/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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