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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscopic irrigation/suction system
510(k) Number K030765
Device Name HOBBS MISTIFIER SPRAY CATHETER
Applicant
HOBBS MEDICAL, INC.
8 SPRING ST.
P.O. BOX 46
STAFFORD SPRINGS,  CT  06076
Applicant Contact ROB WHALEN
Correspondent
HOBBS MEDICAL, INC.
8 SPRING ST.
P.O. BOX 46
STAFFORD SPRINGS,  CT  06076
Correspondent Contact ROB WHALEN
Regulation Number876.1500
Classification Product Code
OCX  
Subsequent Product Code
EOQ  
Date Received03/11/2003
Decision Date 06/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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