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510(k) K080565

MODIFICATION TO: SAVI APPLICATOR KIT by Cianna Medical, Inc. — Product Code JAQ

Clearance Details

Decision
SESU ()
Decision Date
April 4, 2008
Date Received
February 29, 2008
Clearance Type
Special
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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  • K101411 — SAVI PREPARATION DEVICE (July 12, 2010)
  • K081677 — SAVI APPLICATOR KIT (July 22, 2008)

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