FDA 510(k) Application Details - K030765

Device Classification Name Endoscopic Irrigation/Suction System

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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
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Regulation Number 876.1500

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Classification Product Code OCX
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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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