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510(k) K092534

ALATUS VAGINAL BALLOON PACKING SYSTEM by Radiadyne — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2009
Date Received
August 19, 2009
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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