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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Device Disinfectant
510(k) Number K121171
Device Name CUROS TIP
Applicant
Ivera Medical, Inc.
2731 Loker Ave. W.
Carlsbad,  CA  92010
Applicant Contact DON CANAL
Correspondent
Ivera Medical, Inc.
2731 Loker Ave. W.
Carlsbad,  CA  92010
Correspondent Contact DON CANAL
Regulation Number880.5440
Classification Product Code
QBP  
Date Received04/17/2012
Decision Date 11/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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