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FDA 510(k) Application Details - K061871
Device Classification Name
System, X-Ray, Angiographic
More FDA Info for this Device
510(K) Number
K061871
Device Name
System, X-Ray, Angiographic
Applicant
LEICA MICROSYSTEMS, INC.
2337 LUCKY JOHN DRIVE
PARK CITY, UT 84060 US
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Contact
MAX STURGIS
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Regulation Number
892.1600
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Classification Product Code
IZI
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More FDA Info for this Product Code
Date Received
07/03/2006
Decision Date
09/20/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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