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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 K852542
Device Name PALLADIUM SEED MODEL 100
Applicant
Nuclear Medicine, Inc.
900 Atlantic Dr. NW
Atlanta,  GA  30332
Applicant Contact JOHN L RUSSELL
Correspondent
Nuclear Medicine, Inc.
900 Atlantic Dr. NW
Atlanta,  GA  30332
Correspondent Contact JOHN L RUSSELL
Regulation Number892.5730
Classification Product Code
IWI  
Date Received06/14/1985
Decision Date 01/14/1986
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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