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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K120816
Device Name INZONE DETACHMENT SYSTEM
Applicant
Stryker
47900 BAYSIDE PARKWAY
FREMONT,  CA  94538
Applicant Contact MARA CHOU
Correspondent
Stryker
47900 BAYSIDE PARKWAY
FREMONT,  CA  94538
Correspondent Contact MARA CHOU
Regulation Number870.3300
Classification Product Code
KRD  
Date Received03/19/2012
Decision Date 04/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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