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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
510(k) Number K250518
Device Name SMART M-CELL Bone Marrow Concentration System
Applicant
Miracell Co., Ltd.
Rm. 405, 474 Dunchon-Daero, Jungwon-Gu
Seoul,  KR
Applicant Contact Sy Koo
Correspondent
Mtech Group, LLC
7505 Fannin St.
Suite 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number862.2050
Classification Product Code
QBV  
Date Received02/21/2025
Decision Date 04/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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