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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
Device Name CUROS TIP
Applicant
IVERA MEDICAL, INC.
2731 loker avenue west
carlsbad,  CA  92010
Applicant Contact don canal
Correspondent
IVERA MEDICAL, INC.
2731 loker avenue west
carlsbad,  CA  92010
Correspodent Contact don canal
Classification Product Code
LKB  
Date Received04/17/2012
Decision Date 11/26/2012
Decision substantially equivalent (SESE)
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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