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FDA 510(k)

QUALTEX SKIN MARKER

K-Number: K904559 · 1990-12-13

ApplicantQualtex, Inc.
Decision Date1990-12-13
Product CodeFZZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUALTEX SKIN MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Qualtex, Inc.. It received FDA 510(k) clearance on 1990-12-13 under 510(k) number K904559. 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 QUALTEX SKIN MARKER?

QUALTEX SKIN MARKER is a medical device that received FDA 510(k) clearance on 1990-12-13. The listed applicant is Qualtex, Inc.. The 510(k) number is K904559.

When did QUALTEX SKIN MARKER receive FDA 510(k) clearance?

QUALTEX SKIN MARKER received FDA 510(k) clearance on 1990-12-13, under 510(k) number K904559.

Who is the listed applicant for QUALTEX SKIN MARKER?

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

What is the FDA product code for QUALTEX SKIN MARKER?

The FDA product code for QUALTEX SKIN MARKER 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Qualtex, 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.

K780818LAPAROTOMY SPONGE

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.K896792SURGICAL SKIN MARKERWestmark, Sterile Packing Systems, Inc. (Sps)

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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