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510(k) K212774

VenSure LightGuide by Intersect Ent. — Product Code LRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2022
Date Received
September 1, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ent Manual Surgical
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

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