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FDA 510(k)

BIOMARC GOLD FIDUCIAL MARKER

K-Number: K130678 · 2013-04-12

ApplicantCarbon Medical Technologies, Inc.
Decision Date2013-04-12
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIOMARC GOLD FIDUCIAL MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Carbon Medical Technologies, Inc.. It received FDA 510(k) clearance on 2013-04-12 under 510(k) number K130678. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMARC GOLD FIDUCIAL MARKER?

BIOMARC GOLD FIDUCIAL MARKER is a medical device that received FDA 510(k) clearance on 2013-04-12. The listed applicant is Carbon Medical Technologies, Inc.. The 510(k) number is K130678.

When did BIOMARC GOLD FIDUCIAL MARKER receive FDA 510(k) clearance?

BIOMARC GOLD FIDUCIAL MARKER received FDA 510(k) clearance on 2013-04-12, under 510(k) number K130678.

Who is the listed applicant for BIOMARC GOLD FIDUCIAL MARKER?

The FDA 510(k) record lists Carbon Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOMARC GOLD FIDUCIAL MARKER?

The FDA product code for BIOMARC GOLD FIDUCIAL MARKER is IYE.

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Other records listing Carbon Medical Technologies, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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