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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter, tissue saturation
510(k) Number K073407
Device Name PACIFICA
Original Applicant
2001 pennsylvania ave. nw
suite 950
washington,  DC  20006
Original Contact campbell hutton
Regulation Number870.2700
Classification Product Code
Date Received12/04/2007
Decision Date 02/28/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No