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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 K890100
Device Name PENN-PET SCANNER
Applicant
Ugm Medical Systems, Inc.
404 Oak Ln.
Wayne,  PA  19087
Applicant Contact GERD MUEHLLEHNER
Correspondent
Ugm Medical Systems, Inc.
404 Oak Ln.
Wayne,  PA  19087
Correspondent Contact GERD MUEHLLEHNER
Regulation Number892.1200
Classification Product Code
KPS  
Date Received01/10/1989
Decision Date 04/13/1989
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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