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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 K993701
Device Name PHARMASEED, MODEL BT-125-2
Applicant
Syncor International, Inc.
1313 Washington Ave.
Golden,  CO  80401
Applicant Contact GARY GILMORE
Correspondent
Syncor International, Inc.
1313 Washington Ave.
Golden,  CO  80401
Correspondent Contact GARY GILMORE
Regulation Number892.5730
Classification Product Code
KXK  
Date Received11/02/1999
Decision Date 06/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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