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FDA 510(k) Application Details - K190659
Device Classification Name
Stent, Ureteral
More FDA Info for this Device
510(K) Number
K190659
Device Name
Stent, Ureteral
Applicant
Allwin Medical Devices, Inc.
3305 E. Mira Loma Avenue, Suite 176
Anaheim, CA 92806 US
Other 510(k) Applications for this Company
Contact
Digish Mehta
Other 510(k) Applications for this Contact
Regulation Number
876.4620
More FDA Info for this Regulation Number
Classification Product Code
FAD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/14/2019
Decision Date
12/02/2019
Decision
SESK - SUBST EQUIV - KIT
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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