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FDA 510(k)

BIOMARC TISSUE MARKER

K-Number: K032347 · 2003-08-21

ApplicantCarbon Medical Technologies, Inc.
Decision Date2003-08-21
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOMARC TISSUE 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 2003-08-21 under 510(k) number K032347. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMARC TISSUE MARKER?

BIOMARC TISSUE MARKER is a medical device that received FDA 510(k) clearance on 2003-08-21. The listed applicant is Carbon Medical Technologies, Inc.. The 510(k) number is K032347.

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

BIOMARC TISSUE MARKER received FDA 510(k) clearance on 2003-08-21, under 510(k) number K032347.

Who is the listed applicant for BIOMARC TISSUE 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 TISSUE MARKER?

The FDA product code for BIOMARC TISSUE MARKER is GDW.

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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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