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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 K020300
Device Name NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)
Applicant
Syntermed, Inc.
245 Owens Dr.
Anaheim,  CA  92808
Applicant Contact KENNETH F VAN TRAIN
Correspondent
Syntermed, Inc.
245 Owens Dr.
Anaheim,  CA  92808
Correspondent Contact KENNETH F VAN TRAIN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received01/29/2002
Decision Date 04/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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