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FDA 510(k) Application Details - K230056
Device Classification Name
More FDA Info for this Device
510(K) Number
K230056
Device Name
MiVuÖ Esophageal Endo Cap
Applicant
Diversatek Healthcare
9150 Commerce Center Circle, Suite 500
Highlands Ranch, CO 80129 US
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Contact
Jim Prinster
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Regulation Number
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Classification Product Code
QIS
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Date Received
01/09/2023
Decision Date
04/25/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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