PRESSURE TURING AND ACCESSORIES

Endoscope, Rigid

APPLIED MEDICAL RESOURCES

The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Pressure Turing And Accessories.

Pre-market Notification Details

Device IDK925918
510k NumberK925918
Device Name:PRESSURE TURING AND ACCESSORIES
ClassificationEndoscope, Rigid
Applicant APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills,  CA  92653
ContactJo Stegwell
CorrespondentJo Stegwell
APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills,  CA  92653
Product CodeGCM  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-23
Decision Date1993-02-12

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