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510(k) K032347

BIOMARC TISSUE MARKER by Carbon Medical Technologies, Inc. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2003
Date Received
July 30, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type

Other clearances by Carbon Medical Technologies, Inc.

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  • K172227 — Endoscopic Injection Needle (August 23, 2017)
  • K133148 — BIOMARC COAXIAL NEEDLE (May 13, 2014)
  • K132064 — BIOMARC FIDUCIAL MARKER (February 28, 2014)
  • K132708 — BIOMARC FIDUCIAL MARKER (December 20, 2013)
  • K130678 — BIOMARC GOLD FIDUCIAL MARKER (April 12, 2013)
  • K110772 — BIOMARC FIDUCIAL MARKER (April 28, 2011)
  • K100994 — PRELOADED TISSUE MARKER DEVICE (April 30, 2010)

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