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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K982226
Device Name UROMED BRACHYTHERAPHY IODINE-125 SOURCES
Applicant
Uromed Corp.
64 A St.
Needham,  MA  02194
Applicant Contact FREDERICK TOBIA
Correspondent
Uromed Corp.
64 A St.
Needham,  MA  02194
Correspondent Contact FREDERICK TOBIA
Regulation Number892.5730
Classification Product Code
KXK  
Date Received06/24/1998
Decision Date 05/13/1999
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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