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FDA 510(k) Application Details - K030765
Device Classification Name
Endoscopic Irrigation/Suction System
More FDA Info for this Device
510(K) Number
K030765
Device Name
Endoscopic Irrigation/Suction System
Applicant
HOBBS MEDICAL, INC.
8 SPRING ST.
P.O. BOX 46
STAFFORD SPRINGS, CT 06076 US
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Contact
ROB WHALEN
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
OCX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/11/2003
Decision Date
06/09/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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