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FDA 510(k) Application Details - K190208
Device Classification Name
System, Gastrointestinal Motility (Electrical)
More FDA Info for this Device
510(K) Number
K190208
Device Name
System, Gastrointestinal Motility (Electrical)
Applicant
Diversatek Healthcare
9150 Commerce Center Circle
Suite 500
Highlands Ranch, CO 80129 US
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Contact
Laura L. Boll
Other 510(k) Applications for this Contact
Regulation Number
876.1725
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Classification Product Code
FFX
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More FDA Info for this Product Code
Date Received
02/04/2019
Decision Date
10/03/2019
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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