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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 K875378
Device Name SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION
Applicant
Shimadzu Precision Instruments, Inc.
20410 Earl St.
Torrance,  CA  90503
Applicant Contact HIROYUKI HATTORI
Correspondent
Shimadzu Precision Instruments, Inc.
20410 Earl St.
Torrance,  CA  90503
Correspondent Contact HIROYUKI HATTORI
Regulation Number892.1200
Classification Product Code
KPS  
Date Received12/31/1987
Decision Date 11/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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