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FDA 510(k) Application Details - K180725
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K180725
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
Aspire Bariatrics, Inc.
3200 Horizon Drive, Suite 100
King of Prussia, PA 19406 US
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Contact
Monica Ferrante
Other 510(k) Applications for this Contact
Regulation Number
876.5980
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Classification Product Code
KNT
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More FDA Info for this Product Code
Date Received
03/20/2018
Decision Date
07/11/2018
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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