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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
  View current 510(K) holder
Current 510(k) Holder *
MACBRUD CORP., MEDICAL DIVISION
12101 SW 131 Avenue
miami,  FL  33186
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

 
* Reported through Establishment Registration and Device Listing
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