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FDA 510(k) Application Details - K050808
Device Classification Name
Angioscope
More FDA Info for this Device
510(K) Number
K050808
Device Name
Angioscope
Applicant
CARDIO-OPTICS, INC.
2477 55TH ST., SUITE 120
BOULDER, CO 80301 US
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Contact
LARRY BLANKENSHIP
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
LYK
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More FDA Info for this Product Code
Date Received
03/30/2005
Decision Date
07/28/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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