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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, ent manual surgical
510(k) Number K212774
Device Name VenSure LightGuide
Applicant
Intersect ENT
1555 Adams Dr.
Menlo Park,  CA  94025
Applicant Contact Yoko Enrile
Correspondent
Intersect ENT
1555 Adams Dr.
Menlo Park,  CA  94025
Correspondent Contact Yoko Enrile
Regulation Number874.4420
Classification Product Code
LRC  
Date Received09/01/2021
Decision Date 02/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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