CUROS TIP

Cap, Device Disinfectant

IVERA MEDICAL, INC.

The following data is part of a premarket notification filed by Ivera Medical, Inc. with the FDA for Curos Tip.

Pre-market Notification Details

Device IDK121171
510k NumberK121171
Device Name:CUROS TIP
ClassificationCap, Device Disinfectant
Applicant IVERA MEDICAL, INC. 2731 LOKER AVENUE WEST Carlsbad,  CA  92010
ContactDon Canal
CorrespondentDon Canal
IVERA MEDICAL, INC. 2731 LOKER AVENUE WEST Carlsbad,  CA  92010
Product CodeQBP  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-17
Decision Date2012-11-26
Summary:summary

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