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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 K032063
Device Name PEM 2400 PET SCANNER
Applicant
Pem Technologies
7617 Standish Pl.
Rockville,  MD  20855
Applicant Contact IRVING WEINBERG
Correspondent
Pem Technologies
7617 Standish Pl.
Rockville,  MD  20855
Correspondent Contact IRVING WEINBERG
Regulation Number892.1200
Classification Product Code
KPS  
Date Received07/03/2003
Decision Date 08/18/2003
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
Recalls CDRH Recalls
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