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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, mammographic
510(k) Number K123414
Device Name SPECBOARD JR.
Applicant
MACBRUD CORP., MEDICAL DIVISION
14021 SW 143 COURT, UNIT 6
MIAMI,  FL  33186
Applicant Contact TODD LARY
Correspondent
MACBRUD CORP., MEDICAL DIVISION
14021 SW 143 COURT, UNIT 6
MIAMI,  FL  33186
Correspondent Contact TODD LARY
Regulation Number892.1710
Classification Product Code
IZH  
Date Received11/06/2012
Decision Date 01/11/2013
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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