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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name balloon aortic valvuloplasty
510(k) Number K122012
Device Name Z-MED Z-MED II
Applicant
NUMED, INC.
2880 main st.
hopkinton,  NY  12965
Applicant Contact nichelle laflesh
Correspondent
NUMED, INC.
2880 main st.
hopkinton,  NY  12965
Correspodent Contact nichelle laflesh
Regulation Number870.1255
Classification Product Code
OZT  
Date Received07/10/2012
Decision Date 10/04/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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