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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 K945721
Device Name PENN-PET SCANNER
Applicant
Ugm Medical Systems, Inc.
3401 Market St.
Suite 222
Philadelphia,  PA  19104
Applicant Contact GERD MUEHLLEHNER
Correspondent
Ugm Medical Systems, Inc.
3401 Market St.
Suite 222
Philadelphia,  PA  19104
Correspondent Contact GERD MUEHLLEHNER
Regulation Number892.1200
Classification Product Code
KPS  
Date Received11/21/1994
Decision Date 04/07/1995
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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