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FDA 510(k) Application Details - K220114
Device Classification Name
Syringe, Antistick
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
MEG
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More FDA Info for this Product Code
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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