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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 K142801
Device Name Triton Canister System
Applicant
Gauss Surgical, Inc.,
334 State St., Suite 201
Los Altos,  CA  94022
Applicant Contact Peggy McLaughlin
Correspondent
Gauss Surgical, Inc.,
334 State St., Suite 201
Los Altos,  CA  94022
Correspondent Contact Peggy McLaughlin
Regulation Number880.2750
Classification Product Code
PBZ  
Date Received09/29/2014
Decision Date 03/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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