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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, planning, radiation therapy treatment
510(k) Number K180289
Device Name 3D Bolus Software
Applicant
3D Bolus, Inc.
1344 Summer St
Suite 3015
halifax,  CA b3h 0a8
Applicant Contact peter hickey
Correspondent
3D Bolus, Inc.
1344 Summer St
Suite 3015
halifax,  CA b3h 0a8
Correspondent Contact peter hickey
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received02/01/2018
Decision Date 07/10/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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