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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diagnostic Neurosurgical Microscope Filter
510(k) Number K251286
Device Name Affirm 400
Applicant
Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
125 Cremona Dr.
Suite 110
Goleta,  CA  93117
Applicant Contact Lu Ju
Correspondent
Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
125 Cremona Dr.
Suite 110
Goleta,  CA  93117
Correspondent Contact Lu Ju
Regulation Number882.4950
Classification Product Code
QFX  
Date Received04/25/2025
Decision Date 01/21/2026
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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