UROLOGICAL GUIDWIRE

Accessories, Catheter, G-u

APPLIED MEDICAL RESOURCES

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

Pre-market Notification Details

Device IDK944135
510k NumberK944135
Device Name:UROLOGICAL GUIDWIRE
ClassificationAccessories, Catheter, G-u
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 CodeKNY  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-24
Decision Date1994-09-21

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