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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cement, bone, vertebroplasty
510(k) Number K113477
Model 0705-120-500
Device Name IVAS 20MM (10 GAUGE) BALLOON CATHETER
Original Applicant
STRYKER INSTRUMENTS, INSTRUMENTS DIV.
4100 east milham ave.
kalamazoo,  MI  49001
Original Contact christina mckee
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received11/23/2011
Decision Date 01/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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