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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Blood-Flow, Extravascular
510(k) Number K962700
Device Name VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT
Applicant
Vasamedics, LLC
2963 Yorkton Blvd.
Saint Paul,  MN  55117 -1064
Applicant Contact DOUGLAS G TOMASKO
Correspondent
Vasamedics, LLC
2963 Yorkton Blvd.
Saint Paul,  MN  55117 -1064
Correspondent Contact DOUGLAS G TOMASKO
Regulation Number870.2120
Classification Product Code
DPT  
Date Received07/12/1996
Decision Date 04/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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