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FDA 510(k) Application Details - K961368
Device Classification Name
Probe, Blood-Flow, Extravascular
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510(K) Number
K961368
Device Name
Probe, Blood-Flow, Extravascular
Applicant
VASAMEDICS, L.L.C.
2963 YORKTON BLVD.
SAINT PAUL, MN 55117-1064 US
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Contact
DOUGLAS G TOMASKO
Other 510(k) Applications for this Contact
Regulation Number
870.2120
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Classification Product Code
DPT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/09/1996
Decision Date
10/11/1996
Decision
SESK - SUBST EQUIV - KIT
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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