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510(k) K232308

Monarch Blood Collection Set by The Monarch Company — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2023
Date Received
August 2, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

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