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FDA 510(k) Application Details - K203199
Device Classification Name
Washer, Cleaner, Automated, Endoscope
More FDA Info for this Device
510(K) Number
K203199
Device Name
Washer, Cleaner, Automated, Endoscope
Applicant
STERIS Corporation
5960 Heisley Road
Mentor, OH 44060 US
Other 510(k) Applications for this Company
Contact
Jennifer Nalepka
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
NVE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/29/2020
Decision Date
12/01/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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