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FDA 510(k) Application Details - K092612
Device Classification Name
More FDA Info for this Device
510(K) Number
K092612
Device Name
D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505
Applicant
VASCULAR SOLUTIONS, INC.
6464 SYCAMORE COURT
MINNEAPOLIS, MN 55369 US
Other 510(k) Applications for this Company
Contact
LISA GALLATIN
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QSX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/26/2009
Decision Date
09/11/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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