APPLIED MEDICAL OPTICAL VALVULOTOME

Angioscope

APPLIED MEDICAL RESOURCES

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

Pre-market Notification Details

Device IDK945591
510k NumberK945591
Device Name:APPLIED MEDICAL OPTICAL VALVULOTOME
ClassificationAngioscope
Applicant APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills,  CA  92653
ContactMary J Stegwell
CorrespondentMary J Stegwell
APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills,  CA  92653
Product CodeLYK  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-14
Decision Date1995-02-10

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