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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 K121345
Device Name SR SUITE 1.0
Original Applicant
HALIFAX BIOMEDICAL, INC.
8870 ravello ct
naples,  FL  34114
Original Contact daniel kamm
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Codes
LLZ   MQB  
Date Received05/04/2012
Decision Date 06/01/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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