FDA 510(k) Application Details - K962700

Device Classification Name Probe, Blood-Flow, Extravascular

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510(K) Number K962700
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
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Regulation Number 870.2120

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Classification Product Code DPT
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Date Received 07/12/1996
Decision Date 04/09/1997
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 N
Expedited Review



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