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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pad, alcohol, device disinfectant
510(K) Number K121171
Model 003-300
Device Name CUROS TIP
Applicant
IVERA MEDICAL, INC.
2731 loker avenue west
carlsbad,  CA  92010
Contact don canal
Classification Product Code
LKB  
Date Received04/17/2012
Decision Date 11/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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