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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
Device Name PIXEL APP
Applicant
Gauss Surgical, Inc.,
22700 Alcalde Rd.
Cupertino,  CA  95014
Applicant Contact PEGGY MCLAUGHLIN
Correspondent
Gauss Surgical, Inc.,
22700 Alcalde Rd.
Cupertino,  CA  95014
Correspondent Contact PEGGY MCLAUGHLIN
Regulation Number880.2740
Classification Product Code
LWH  
Date Received04/27/2012
Decision Date 06/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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