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FDA 510(k) Application Details - K231907
Device Classification Name
Syringe, Antistick
More FDA Info for this Device
510(K) Number
K231907
Device Name
Syringe, Antistick
Applicant
Medline Industries, LP
Three Lakes Drive
Northfield, IL 60093 US
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Contact
Kelsey Closen
Other 510(k) Applications for this Contact
Regulation Number
880.5860
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Classification Product Code
MEG
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More FDA Info for this Product Code
Date Received
06/29/2023
Decision Date
10/18/2023
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 K231907
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