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510(k) K122840

CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 by Mick Radio-Nuclear Instruments, Inc. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2012
Date Received
September 17, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type

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