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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 K011205
Device Name ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125
Applicant
Isoaid
962 Allegro Ln.
Appollo Beach,  FL  33572
Applicant Contact ART WARD
Correspondent
Isoaid
962 Allegro Ln.
Appollo Beach,  FL  33572
Correspondent Contact ART WARD
Regulation Number892.5730
Classification Product Code
KXK  
Date Received04/19/2001
Decision Date 07/10/2001
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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