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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K120381
Device Name Q50 PLUS STENT GRAFT BALLOON CATHETER
Applicant
Qxmedical, LLC
1747 Summit Ave.
St. Paul,  MN  55105
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
MJN  
Date Received02/07/2012
Decision Date 02/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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