FDA 510(k) Application Details - K242255

Device Classification Name Stopcock, I.V. Set

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510(K) Number K242255
Device Name Stopcock, I.V. Set
Applicant Medex
240 Allee Jacques Monod
Saint-Priest 69800 FR
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Contact Guylaine Casses
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Regulation Number 880.5440

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Classification Product Code FMG
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Date Received 07/31/2024
Decision Date 04/29/2025
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242255


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