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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Manual
510(k) Number K980997
Device Name PGK DEVICE (MODIFIED)
Applicant
Pgk, Inc.
8320 Old Ct.house Rd.
Suite 150
Vienna,  VA  22182
Applicant Contact PANOS G KOUTROUVELIS
Correspondent
Pgk, Inc.
8320 Old Ct.house Rd.
Suite 150
Vienna,  VA  22182
Correspondent Contact PANOS G KOUTROUVELIS
Regulation Number892.5650
Classification Product Code
IWJ  
Date Received03/17/1998
Decision Date 09/28/1998
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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