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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K130430
Device Name IVAS 10MM AND 15MM 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 Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
NDN  
Date Received02/20/2013
Decision Date 05/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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