FDA 510(k) Application Details - K211649

Device Classification Name

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510(K) Number K211649
Device Name PCEA Syringe Set
Applicant Baxter Healthcare Corporation
25212 West Illinois Route 120
Round Lake, IL 60073 US
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Contact Jeffrey E Thompson
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Regulation Number

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Classification Product Code PWH
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Date Received 05/28/2021
Decision Date 11/23/2021
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



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