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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 K090070
Device Name INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
Applicant
Invuity, Inc.
155-A Moffett Park Dr.,
Suite 210
Sunnyvale,  CA  94089
Applicant Contact KIT CARIQUITAN
Correspondent
Invuity, Inc.
155-A Moffett Park Dr.,
Suite 210
Sunnyvale,  CA  94089
Correspondent Contact KIT CARIQUITAN
Regulation Number878.4580
Classification Product Code
FST  
Date Received01/12/2009
Decision Date 04/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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