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510(k) K030110

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2003
Date Received
January 13, 2003
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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