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FDA 510(k) Application Details - K191438
Device Classification Name
Endoscopic Irrigation/Suction System
More FDA Info for this Device
510(K) Number
K191438
Device Name
Endoscopic Irrigation/Suction System
Applicant
Erbe USA, Inc.
2225 Northwest Parkway
Marietta, GA 30067 US
Other 510(k) Applications for this Company
Contact
John Tartal
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
OCX
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More FDA Info for this Product Code
Date Received
05/30/2019
Decision Date
06/27/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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