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FDA 510(k) Application Details - K993778
Device Classification Name
Endoscopic Irrigation/Suction System
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510(K) Number
K993778
Device Name
Endoscopic Irrigation/Suction System
Applicant
NORTHGATE TECHNOLOGIES, INC.
600 CHURCH RD.
ELGIN, IL 60123 US
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Contact
CASEY KUREK
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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
11/08/1999
Decision Date
01/06/2000
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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