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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 K891090
Device Name SPECBOARD
Applicant
MACBRUD CORP. MEDICAL DIV.
6280 SUNSET DRIVE #411
MIAMI,  FL  33143
Applicant Contact LARY, MD
Correspondent
MACBRUD CORP. MEDICAL DIV.
6280 SUNSET DRIVE #411
MIAMI,  FL  33143
Correspondent Contact LARY, MD
Regulation Number892.1710
Classification Product Code
IZH  
Date Received03/06/1989
Decision Date 04/07/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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