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FDA 510(k) Application Details - K000825
Device Classification Name
Catheter, Intravascular, Diagnostic
More FDA Info for this Device
510(K) Number
K000825
Device Name
Catheter, Intravascular, Diagnostic
Applicant
MEDI-DYNE, INC.
604 QUEENSBURY AVE.
QUEENSBURY, NY 12804 US
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Contact
NORMAN HALL
Other 510(k) Applications for this Contact
Regulation Number
870.1200
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Classification Product Code
DQO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/14/2000
Decision Date
09/21/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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