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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name counter, sponge, surgical
510(k) Number K121274
Model PIXEL APP 2.0
Device Name PIXEL APP
Original Applicant
GAUSS SURGICAL, INC.
22700 alcalde rd
cupertino,  CA  95014
Original Contact peggy mclaughlin
Regulation Number880.2740
Classification Product Code
LWH  
Date Received04/27/2012
Decision Date 06/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General & Plastic Surgery
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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