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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name accelerator, linear, medical
510(k) Number K213053
Device Name Gold Anchor
Naslund Medical AB
Avagen 40 B
Huddinge,  SE 14130
Applicant Contact Tomas Näslund
Naslund Medical AB
Avagen 40 B
Huddinge,  SE 14130
Correspondent Contact Tomas Näslund
Regulation Number892.5050
Classification Product Code
Date Received09/22/2021
Decision Date 01/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No