FDA 510(k) Application Details - K202357

Device Classification Name

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510(K) Number K202357
Device Name Nutricare Clear-ISOSAF Nasogastric Feeding Tube
Applicant Three Circles Consulting Limited
MED IC4, Keele University Science & Innovation Park
Keele ST5 5NL GB
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Contact Matthew Theobald
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Regulation Number

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Classification Product Code PIF
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Date Received 08/19/2020
Decision Date 10/01/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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