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FDA 510(k) Application Details - K963703
Device Classification Name
Probe, Blood-Flow, Extravascular
More FDA Info for this Device
510(K) Number
K963703
Device Name
Probe, Blood-Flow, Extravascular
Applicant
INTERNATIONAL BIOPHYSICS CORP.
4020 SOUTH INDUSTRIAL DR.
SUITE 160
AUSTIN, TX 78744 US
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Contact
H. DAVID SHOCKLEY, JR.
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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
09/16/1996
Decision Date
04/08/1998
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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