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FDA 510(k)

PEN, MARK-3 SKIN MARKING FOUNTAIN

K-Number: K781694 · 1978-12-04

ApplicantOmega Mark-3 Pen Corp.
Decision Date1978-12-04
Product CodeFZZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PEN, MARK-3 SKIN MARKING FOUNTAIN is the device name listed in this FDA 510(k) record. The listed applicant is Omega Mark-3 Pen Corp.. It received FDA 510(k) clearance on 1978-12-04 under 510(k) number K781694. The device is classified under product code FZZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEN, MARK-3 SKIN MARKING FOUNTAIN?

PEN, MARK-3 SKIN MARKING FOUNTAIN is a medical device that received FDA 510(k) clearance on 1978-12-04. The listed applicant is Omega Mark-3 Pen Corp.. The 510(k) number is K781694.

When did PEN, MARK-3 SKIN MARKING FOUNTAIN receive FDA 510(k) clearance?

PEN, MARK-3 SKIN MARKING FOUNTAIN received FDA 510(k) clearance on 1978-12-04, under 510(k) number K781694.

Who is the listed applicant for PEN, MARK-3 SKIN MARKING FOUNTAIN?

The FDA 510(k) record lists Omega Mark-3 Pen Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEN, MARK-3 SKIN MARKING FOUNTAIN?

The FDA product code for PEN, MARK-3 SKIN MARKING FOUNTAIN is FZZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FZZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K042555SURGICHIP TAG SURGICAL MARKERSurgichip, Inc.K915066DISPOSABLE SKIN MARKERAmerican Medical Mfg., Inc.K914759BLOOM TRANSPARENT STENCILFreckles Publications, Inc.K912730ROCKET SURGICAL SKIN MARKING PENWest Texas Lighthouse For the BlindK905143SKIN MARKERAesculap, Inc.K904559QUALTEX SKIN MARKERQualtex, Inc.

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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