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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Isotope, Sealed, Gold, Titanium, Platinum
510(k) Number K874787
Device Name MODIFIED PALLADIUM SEED MODEL 100
Applicant
Theragenics Corp.
900 Atlantic Dr., NW
Atlanta,  GA  30318
Applicant Contact WILLIAM H DUFFELL
Correspondent
Theragenics Corp.
900 Atlantic Dr., NW
Atlanta,  GA  30318
Correspondent Contact WILLIAM H DUFFELL
Regulation Number892.5730
Classification Product Code
IWI  
Date Received11/23/1987
Decision Date 12/22/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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