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FDA 510(k) Application Details - K220256
Device Classification Name
More FDA Info for this Device
510(K) Number
K220256
Device Name
MIM-Ablation
Applicant
MIM Software Inc.
25800 Science Park Drive - Suite 180
Cleveland, OH 44122 US
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Contact
Daniel Darkow
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Regulation Number
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Classification Product Code
QTZ
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More FDA Info for this Product Code
Date Received
01/31/2022
Decision Date
10/07/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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