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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drills, Burrs, Trephines & Accessories (Simple, Powered)
510(k) Number K250380
Device Name Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)
Applicant
Surgify Medical OY
Otakaari 5
Espoo,  FI 02150
Applicant Contact Jukka Kreander
Correspondent
Avania, LLC
3031 Tisch Way
Suite 1010
San Jose,  CA  95128
Correspondent Contact Richard Lilly
Regulation Number882.4310
Classification Product Code
HBE  
Date Received02/11/2025
Decision Date 03/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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