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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transducer, blood-pressure, extravascular
510(k) Number K101518
Device Name COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE
Applicant
MIRADOR BIOMEDICAL, INC.
2815 WASTLAKE AVENUE
SUITE 300
SEATTLE,  WA  98102
Applicant Contact JUSTIN HULVERSHORN MD, PHD
Correspondent
MIRADOR BIOMEDICAL, INC.
2815 WASTLAKE AVENUE
SUITE 300
SEATTLE,  WA  98102
Correspondent Contact JUSTIN HULVERSHORN MD, PHD
Regulation Number870.2850
Classification Product Code
DRS  
Subsequent Product Code
DXG  
Date Received06/02/2010
Decision Date 10/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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