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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K232308
Device Name Monarch Blood Collection Set
Applicant
The Monarch Company
4000 Eagle Point Corporate Dr.
Birmingham,  AL  35242
Applicant Contact Jonathan Trawick
Correspondent
The Monarch Company
4000 Eagle Point Corporate Dr.
Birmingham,  AL  35242
Correspondent Contact Pooja Kannam
Regulation Number862.1675
Classification Product Code
JKA  
Date Received08/02/2023
Decision Date 12/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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