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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 K123942
Device Name STRYKER IVAS BALLOON CATHETER
Applicant
Stryker Corporation
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact CHRISTINA MCKEE
Correspondent
Stryker Corporation
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact CHRISTINA MCKEE
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received12/20/2012
Decision Date 04/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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