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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, tomography, computed, emission
510(k) Number K001888
Device Name UNICORN MODEL SYS0630
Applicant
DANISH DIAGNOSTIC DEVELOPMENT A/S
2970 HORSHOM,  DK 2970
Applicant Contact NEERGAARDSVEJ 5F
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact R. KENT DONOHUE
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/15/2000
Decision Date 06/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
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