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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name image processing device for estimation of external blood loss
510(k) Number K163507
Device Name Triton Sponge System
Applicant
Gauss Surgical, Inc.
334 State St., Suite 201
Los Altos,  CA  94022
Applicant Contact Artie Kaushik
Correspondent
Gauss Surgical, Inc.
334 State St., Suite 201
Los Altos,  CA  94022
Correspondent Contact Artie Kaushik
Regulation Number880.2750
Classification Product Code
PBZ  
Date Received12/14/2016
Decision Date 04/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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