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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K911974
Device Name PGK STEREOTACTIC DEVICE
Applicant
Northern Virginia Radiology and Nuclear Medicine
Seven Corners Medical Bldg.
6305 Castle Pl.
Falls Church,  VA  22044
Applicant Contact PANOS KOUTROUVELIS
Correspondent
Northern Virginia Radiology and Nuclear Medicine
Seven Corners Medical Bldg.
6305 Castle Pl.
Falls Church,  VA  22044
Correspondent Contact PANOS KOUTROUVELIS
Regulation Number888.1100
Classification Product Code
HRX  
Date Received05/03/1991
Decision Date 11/05/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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