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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K162053
Device Name PhotonBlade
Applicant
Invuity Inc.
444 De Haro Street
San Francisco,  CA  94107
Applicant Contact John Kang
Correspondent
Invuity Inc.
444 De Haro Street
San Francisco,  CA  94107
Correspondent Contact John Kang
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/25/2016
Decision Date 09/15/2016
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
Recalls CDRH Recalls
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