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FDA 510(k)

DISPOSABLE SKIN MARKER

K-Number: K915066 · 1992-05-14

ApplicantAmerican Medical Mfg., Inc.
Decision Date1992-05-14
Product CodeFZZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SKIN MARKER is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Mfg., Inc.. It received FDA 510(k) clearance on 1992-05-14 under 510(k) number K915066. 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 DISPOSABLE SKIN MARKER?

DISPOSABLE SKIN MARKER is a medical device that received FDA 510(k) clearance on 1992-05-14. The listed applicant is American Medical Mfg., Inc.. The 510(k) number is K915066.

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

DISPOSABLE SKIN MARKER received FDA 510(k) clearance on 1992-05-14, under 510(k) number K915066.

Who is the listed applicant for DISPOSABLE SKIN MARKER?

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

What is the FDA product code for DISPOSABLE SKIN MARKER?

The FDA product code for DISPOSABLE 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.

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Other records listing American Medical Mfg., 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.

K982029SHARPS COLLECTION CONTAINER - SAF-T-SHELLK961454AMMI MAGNI-GUARDK915064DISPOSABLE CAUTERY ABRASIVE PADK915065I.V.IRRIGATION POLEK915068PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER

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.K914759BLOOM TRANSPARENT STENCILFreckles Publications, Inc.K912730ROCKET SURGICAL SKIN MARKING PENWest Texas Lighthouse For the BlindK905143SKIN MARKERAesculap, Inc.K904559QUALTEX SKIN MARKERQualtex, Inc.K896792SURGICAL SKIN MARKERWestmark, Sterile Packing Systems, Inc. (Sps)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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