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FDA 510(k)

ACCU-LINE SURGICAL MARKER

K-Number: K830298 · 1983-06-02

ApplicantAccu-Line
Decision Date1983-06-02
Product CodeFZZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCU-LINE SURGICAL MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Accu-Line. It received FDA 510(k) clearance on 1983-06-02 under 510(k) number K830298. 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 ACCU-LINE SURGICAL MARKER?

ACCU-LINE SURGICAL MARKER is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is Accu-Line. The 510(k) number is K830298.

When did ACCU-LINE SURGICAL MARKER receive FDA 510(k) clearance?

ACCU-LINE SURGICAL MARKER received FDA 510(k) clearance on 1983-06-02, under 510(k) number K830298.

Who is the listed applicant for ACCU-LINE SURGICAL MARKER?

The FDA 510(k) record lists Accu-Line as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCU-LINE SURGICAL MARKER?

The FDA product code for ACCU-LINE SURGICAL 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.

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Other records listing Accu-Line 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.

K831847JEJUNOSTOMY KITK831636PERCUTANEOUS INTRODUCER KITK831637ACCU-FLUSH

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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