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FDA 510(k) Application Details - K210915
Device Classification Name
Gastroscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K210915
Device Name
Gastroscope And Accessories, Flexible/Rigid
Applicant
Neptune Medical, Inc.
1828 El Camino Real, Suite 508
Burlingame, CA 94010 US
Other 510(k) Applications for this Company
Contact
Alex Tilson
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
FDS
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More FDA Info for this Product Code
Date Received
03/29/2021
Decision Date
05/25/2021
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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