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FDA 510(k) Application Details - K992142
Device Classification Name
Catheter, Intravascular, Diagnostic
More FDA Info for this Device
510(K) Number
K992142
Device Name
Catheter, Intravascular, Diagnostic
Applicant
SCIMED
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566 US
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Contact
MELANIE RASKA
Other 510(k) Applications for this Contact
Regulation Number
870.1200
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Classification Product Code
DQO
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More FDA Info for this Product Code
Date Received
06/24/1999
Decision Date
07/21/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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