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FDA 510(k) Applications for Medical Device Product Code "PBZ"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K160338
GAUSS SURGICAL INC.
Triton System
08/05/2016
DEN130015
GAUSS SURGICAL, INC.
PIXEL 3 SYSTEM
05/09/2014
K142801
Gauss Surgical, Inc.
Triton Canister System
03/12/2015
K163507
Gauss Surgical, Inc.
Triton Sponge System
04/25/2017
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