FDA 510(k) Application Details - K232205

Device Classification Name Pump, Infusion, Enteral

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510(K) Number K232205
Device Name Pump, Infusion, Enteral
Applicant Vesco Medical, LLC
60 Collegeview Road, Suite 144
Westerville, OH 43081 US
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Contact Chris O'Keefe
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Regulation Number 880.5725

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Classification Product Code LZH
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Date Received 07/25/2023
Decision Date 10/23/2023
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 K232205


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