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FDA 510(k)

ROCKET SURGICAL SKIN MARKING PEN

K-Number: K912730 · 1991-11-07

ApplicantWest Texas Lighthouse For the Blind
Decision Date1991-11-07
Product CodeFZZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ROCKET SURGICAL SKIN MARKING PEN is the device name listed in this FDA 510(k) record. The listed applicant is West Texas Lighthouse For the Blind. It received FDA 510(k) clearance on 1991-11-07 under 510(k) number K912730. 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 ROCKET SURGICAL SKIN MARKING PEN?

ROCKET SURGICAL SKIN MARKING PEN is a medical device that received FDA 510(k) clearance on 1991-11-07. The listed applicant is West Texas Lighthouse For the Blind. The 510(k) number is K912730.

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

ROCKET SURGICAL SKIN MARKING PEN received FDA 510(k) clearance on 1991-11-07, under 510(k) number K912730.

Who is the listed applicant for ROCKET SURGICAL SKIN MARKING PEN?

The FDA 510(k) record lists West Texas Lighthouse For the Blind as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROCKET SURGICAL SKIN MARKING PEN?

The FDA product code for ROCKET SURGICAL SKIN MARKING PEN 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.K905143SKIN MARKERAesculap, Inc.K904559QUALTEX SKIN MARKERQualtex, 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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