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510(k) K081066

BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 by Medi-Physics, Inc., Dba GE Healthcare — Product Code IWG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 5, 2008
Date Received: April 15, 2008
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Seed, Isotope, Gold, Titanium, Platinum
Device Class: Class II
Regulation Number: 892.5730
Review Panel: RA
Submission Type