FDA 510(k) Application Details - K220114

Device Classification Name Syringe, Antistick

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510(K) Number K220114
Device Name Syringe, Antistick
Applicant Vault Paragon Group, Inc.
189 3rd Street A101
Oakland, CA 94607 US
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Contact Sari Luciano
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 01/14/2022
Decision Date 01/25/2023
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



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