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FDA 510(k) Application Details - K041705
Device Classification Name
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510(K) Number
K041705
Device Name
RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2
Applicant
OMNISONICS MEDICAL TECHNOLOGIES
66 CONCORD STREET, SUITE A
WILMINGTON, MA 01887 US
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Contact
ANNE M KULIS
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Regulation Number
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Classification Product Code
QEY
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Date Received
06/23/2004
Decision Date
09/01/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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