CHOLANGIOGRAPHY CLAMP

Catheter, Cholangiography

APPLIED MEDICAL RESOURCES

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

Pre-market Notification Details

Device IDK924480
510k NumberK924480
Device Name:CHOLANGIOGRAPHY CLAMP
ClassificationCatheter, Cholangiography
Applicant APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills,  CA  92653
ContactHo Stegwell
CorrespondentHo 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 Received1992-09-03
Decision Date1993-03-03

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