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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Uptake, Nuclear
510(k) Number K013751
Device Name HANDHELD GAMMA FINDER (HGF)
Applicant
Silicon Instruments Gmhb
Ostendstrasse 1
Berlin,  DE D-12459
Applicant Contact THOMAS GOEBEL
Correspondent
Silicon Instruments Gmhb
Ostendstrasse 1
Berlin,  DE D-12459
Correspondent Contact THOMAS GOEBEL
Regulation Number892.1320
Classification Product Code
IZD  
Date Received11/13/2001
Decision Date 02/06/2002
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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