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510(k) K130678

BIOMARC GOLD FIDUCIAL MARKER by Carbon Medical Technologies, Inc. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2013
Date Received
March 13, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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  • K100994 — PRELOADED TISSUE MARKER DEVICE (April 30, 2010)
  • K070436 — BIOMARC GOLD TISSUE MARKER (March 16, 2007)

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