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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 K093419
Device Name IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS
Applicant
Stryker Instruments, Instruments Div.
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact BECKY E DITTY
Correspondent
Stryker Instruments, Instruments Div.
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact BECKY E DITTY
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received11/02/2009
Decision Date 03/18/2010
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
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