LINDEN STONE EXTRACTION BALLOON

Stents, Drains And Dilators For The Biliary Ducts

HOBBS MEDICAL, INC.

The following data is part of a premarket notification filed by Hobbs Medical, Inc. with the FDA for Linden Stone Extraction Balloon.

Pre-market Notification Details

Device IDK872509
510k NumberK872509
Device Name:LINDEN STONE EXTRACTION BALLOON
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant HOBBS MEDICAL, INC. P.O. BOX 46 SPRING STREET Stafford Springs,  CT  06076
ContactRobert G Whalen
CorrespondentRobert G Whalen
HOBBS MEDICAL, INC. P.O. BOX 46 SPRING STREET Stafford Springs,  CT  06076
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-24
Decision Date1987-09-22

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