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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, Stationary
510(k) Number K182880
Device Name Halifax Imaging Kit
Applicant
Halifax Biomedical, Inc.
11493 Route 19
Mabou,  CA B0E1X0
Applicant Contact Crystal Jones
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Codes
LLZ   MQB  
Date Received10/15/2018
Decision Date 10/31/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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