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510(k) K011493

MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY by Mentor Corp. — Product Code KPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2002
Date Received
May 15, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Dose, Radionuclide
Device Class
Class II
Regulation Number
892.1360
Review Panel
RA
Submission Type

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