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510(k) K132463

CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM by Cianna Medical, Inc. — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2013
Date Received
August 7, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Radiographic, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

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  • K103215 — CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT (November 15, 2010)
  • K101411 — SAVI PREPARATION DEVICE (July 12, 2010)
  • K081677 — SAVI APPLICATOR KIT (July 22, 2008)
  • K080565 — MODIFICATION TO: SAVI APPLICATOR KIT (April 4, 2008)

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