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510(k) K120804

CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM by Cianna Medical — Product Code PBY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2013
Date Received
March 16, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Temporary Tissue Marker
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.

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