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FDA 510(k) Application Details - K083335
Device Classification Name
More FDA Info for this Device
510(K) Number
K083335
Device Name
MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
Applicant
OMNISONICS MEDICAL TECHNOLOGIES
66 CONCORD STREET, SUITE A
WILMINGTON, MA 01887 US
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Contact
ANNE M KULIS
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/12/2008
Decision Date
12/15/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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