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FDA 510(k)

MOLE-MARKER

K-Number: K840651 · 1984-03-12

ApplicantNotation Systems, Inc.
Decision Date1984-03-12
Product CodeFTY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MOLE-MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Notation Systems, Inc.. It received FDA 510(k) clearance on 1984-03-12 under 510(k) number K840651. The device is classified under product code FTY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOLE-MARKER?

MOLE-MARKER is a medical device that received FDA 510(k) clearance on 1984-03-12. The listed applicant is Notation Systems, Inc.. The 510(k) number is K840651.

When did MOLE-MARKER receive FDA 510(k) clearance?

MOLE-MARKER received FDA 510(k) clearance on 1984-03-12, under 510(k) number K840651.

Who is the listed applicant for MOLE-MARKER?

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

What is the FDA product code for MOLE-MARKER?

The FDA product code for MOLE-MARKER is FTY.

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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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