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FDA 510(k) Application Details - K993765
Device Classification Name
System, X-Ray, Angiographic
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510(K) Number
K993765
Device Name
System, X-Ray, Angiographic
Applicant
MEDIS MEDICAL IMAGING SYSTEMS, B.V.
109 DANBURY RD.
RIDGEFIELD, CT 06877 US
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Contact
DOUGLAS F ORR
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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
11/08/1999
Decision Date
11/26/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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