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FDA 510(k) Application Details - K190469
Device Classification Name
Endoscopic Irrigation/Suction System
More FDA Info for this Device
510(K) Number
K190469
Device Name
Endoscopic Irrigation/Suction System
Applicant
Erbe USA, Inc.
2225 Northwest Parkway
Marietta, GA 30067 US
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Contact
John Tartal
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
OCX
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More FDA Info for this Product Code
Date Received
02/26/2019
Decision Date
05/23/2019
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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