FDA 510(k)

SURGICAL MARKING PEN

K-Number: K761323 · 1977-01-12

ApplicantRichard-Allan Medical Ind., Inc.

Decision Date1977-01-12

Product CodeFZZ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SURGICAL MARKING PEN is the device name listed in this FDA 510(k) record. The listed applicant is Richard-Allan Medical Ind., Inc.. It received FDA 510(k) clearance on 1977-01-12 under 510(k) number K761323. 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 SURGICAL MARKING PEN?

SURGICAL MARKING PEN is a medical device that received FDA 510(k) clearance on 1977-01-12. The listed applicant is Richard-Allan Medical Ind., Inc.. The 510(k) number is K761323.

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

SURGICAL MARKING PEN received FDA 510(k) clearance on 1977-01-12, under 510(k) number K761323.

Who is the listed applicant for SURGICAL MARKING PEN?

The FDA 510(k) record lists Richard-Allan Medical Ind., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL MARKING PEN?

The FDA product code for SURGICAL MARKING PEN is FZZ.

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Other records listing Richard-Allan Medical Ind., Inc. as applicant

K931879REFLEX HTR K924200REFLEX(R) ESC K926297REFLEX ESI K924761STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD K900566RICHARD-ALLAN VESSEL LOOPS K896262TITANIUM LIGATING CLIPS

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Related Devices (Code: FZZ)

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 Blind K905143SKIN 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.