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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Fiberoptic
510(k) Number K113697
Device Name EIGR SURGICAL ILLUMINATION SYSTEM
Applicant
Invuity, Inc.
39 Stillman St.
San Franciso,  CA  94107
Applicant Contact THERESA BRANDNER-ALLEN
Correspondent
Invuity, Inc.
39 Stillman St.
San Franciso,  CA  94107
Correspondent Contact THERESA BRANDNER-ALLEN
Regulation Number878.4580
Classification Product Code
FST  
Date Received12/16/2011
Decision Date 02/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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