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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K242480
Device Name FLASH EVD System (10-0002)
Applicant
7D Surgical Ulc
60 Scarsdale Rd., Unit 118
Toronto,  CA M3B 2R7
Applicant Contact Elena Marenny
Correspondent
7D Surgical Ulc
60 Scarsdale Rd., Unit 118
Toronto,  CA M3B 2R7
Correspondent Contact Elena Marenny
Regulation Number882.4560
Classification Product Code
HAW  
Date Received08/21/2024
Decision Date 12/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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