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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 K925186
Device Name EQUILIBRIUM RADIONUCLIDE ANGIOCARDIORAPHY ANALYSIS
Applicant
Strichman Medical Equipment, Inc.
93 W. Tech Center
Medfield,  MA  02052
Applicant Contact PAUL FRANZOSA
Correspondent
Strichman Medical Equipment, Inc.
93 W. Tech Center
Medfield,  MA  02052
Correspondent Contact PAUL FRANZOSA
Regulation Number892.1200
Classification Product Code
KPS  
Date Received10/14/1992
Decision Date 01/12/1993
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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