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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stents, drains and dilators for the biliary ducts
510(k) Number K872509
Device Name LINDEN STONE EXTRACTION BALLOON
Applicant
HOBBS MEDICAL, INC.
P.O. BOX 46
SPRING STREET
STAFFORD SPRINGS,  CT  06076
Applicant Contact ROBERT G WHALEN
Correspondent
HOBBS MEDICAL, INC.
P.O. BOX 46
SPRING STREET
STAFFORD SPRINGS,  CT  06076
Correspondent Contact ROBERT G WHALEN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received06/24/1987
Decision Date 09/22/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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