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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mechanical Thrombolysis Catheter
510(k) Number K083335
Device Name MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
Applicant
OMNISONICS MEDICAL TECHNOLOGIES
66 CONCORD STREET, SUITE A
WILMINGTON,  MA  01887
Applicant Contact ANNE M KULIS
Correspondent
OMNISONICS MEDICAL TECHNOLOGIES
66 CONCORD STREET, SUITE A
WILMINGTON,  MA  01887
Correspondent Contact ANNE M KULIS
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received11/12/2008
Decision Date 12/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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