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510(k) K103215

CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT by Cianna Medical — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2010
Date Received
November 1, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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