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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 K091117
Device Name ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA
Applicant
Isoaid, LLC
7824 Clark Moody Blvd.
Port Richey,  FL  34668
Applicant Contact BENJAMIN ROEDELL
Correspondent
Isoaid, LLC
7824 Clark Moody Blvd.
Port Richey,  FL  34668
Correspondent Contact BENJAMIN ROEDELL
Regulation Number892.5730
Classification Product Code
KXK  
Date Received04/17/2009
Decision Date 09/15/2009
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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