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FDA 510(k)

SKIN MARKING PEN

K-Number: K781770 · 1978-11-15

ApplicantAbco Dealers, Inc.
Decision Date1978-11-15
Product CodeFZZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SKIN MARKING PEN is the device name listed in this FDA 510(k) record. The listed applicant is Abco Dealers, Inc.. It received FDA 510(k) clearance on 1978-11-15 under 510(k) number K781770. 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 SKIN MARKING PEN?

SKIN MARKING PEN is a medical device that received FDA 510(k) clearance on 1978-11-15. The listed applicant is Abco Dealers, Inc.. The 510(k) number is K781770.

When did SKIN MARKING PEN receive FDA 510(k) clearance?

SKIN MARKING PEN received FDA 510(k) clearance on 1978-11-15, under 510(k) number K781770.

Who is the listed applicant for SKIN MARKING PEN?

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

What is the FDA product code for SKIN MARKING PEN?

The FDA product code for SKIN MARKING PEN is FZZ.

Related Clinical Trials

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Other records listing Abco Dealers, Inc. as applicant

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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