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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Dose, Radionuclide
510(k) Number K011493
Device Name MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY
Applicant
Mentor Corp.
9727 Valley View Rd.
Eden Prairie,  MN  55344
Applicant Contact GEORGE HOEDEMAN
Correspondent
Mentor Corp.
9727 Valley View Rd.
Eden Prairie,  MN  55344
Correspondent Contact GEORGE HOEDEMAN
Regulation Number892.1360
Classification Product Code
KPT  
Date Received05/15/2001
Decision Date 10/01/2002
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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