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FDA 510(k) Application Details - K013939
Device Classification Name
Probe, Blood-Flow, Extravascular
More FDA Info for this Device
510(K) Number
K013939
Device Name
Probe, Blood-Flow, Extravascular
Applicant
JOSTRA AG
478 MEDIA RD.
OXFORD, PA 19363 US
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Contact
KATHLEEN JOHNSON
Other 510(k) Applications for this Contact
Regulation Number
870.2120
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Classification Product Code
DPT
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More FDA Info for this Product Code
Date Received
11/29/2001
Decision Date
12/14/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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