FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER

Catheter, Cholangiography

APPLIED MEDICAL RESOURCES

The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Flexible Laparoscopic Cholangiography Catheter.

Pre-market Notification Details

Device IDK944790
510k NumberK944790
Device Name:FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
ClassificationCatheter, Cholangiography
Applicant APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills,  CA  92653
ContactMary Jo Stegwell
CorrespondentMary Jo Stegwell
APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills,  CA  92653
Product CodeGBZ  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-28
Decision Date1994-11-29

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