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FDA 510(k) Application Details - K213522
Device Classification Name
Saline, Vascular Access Flush
More FDA Info for this Device
510(K) Number
K213522
Device Name
Saline, Vascular Access Flush
Applicant
Amsino International, Inc.
708 Corporate Center Drive
Pomona, CA 91768 US
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Contact
Jane Gao
Other 510(k) Applications for this Contact
Regulation Number
880.5200
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Classification Product Code
NGT
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More FDA Info for this Product Code
Date Received
11/03/2021
Decision Date
03/22/2022
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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