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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K260166
Device Name Bunkerhill Contrast CAC
Applicant
BunkerHill Health
436 Bryant St.
San Francisco,  CA  94107
Applicant Contact Eren Alkan
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number892.1750
Classification Product Code
JAK  
Date Received01/20/2026
Decision Date 03/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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