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FDA 510(k)

SURGICAL SKIN MARKER

K-Number: K896792 · 1989-12-27

ApplicantWestmark, Sterile Packing Systems, Inc. (Sps)
Decision Date1989-12-27
Product CodeFZZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL SKIN MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Westmark, Sterile Packing Systems, Inc. (Sps). It received FDA 510(k) clearance on 1989-12-27 under 510(k) number K896792. 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 SKIN MARKER?

SURGICAL SKIN MARKER is a medical device that received FDA 510(k) clearance on 1989-12-27. The listed applicant is Westmark, Sterile Packing Systems, Inc. (Sps). The 510(k) number is K896792.

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

SURGICAL SKIN MARKER received FDA 510(k) clearance on 1989-12-27, under 510(k) number K896792.

Who is the listed applicant for SURGICAL SKIN MARKER?

The FDA 510(k) record lists Westmark, Sterile Packing Systems, Inc. (Sps) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL SKIN MARKER?

The FDA product code for SURGICAL SKIN MARKER is FZZ.

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Other records listing Westmark, Sterile Packing Systems, Inc. (Sps) 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.

K896800IRRIGATION TRAYK896799PARACERVICAL/PUDENDAL TRAYSK896559INFANT FEEDING TUBEK896794SPECIMEN CONTAINERK896806CATHETER PLUG/PROTECTORK896798TRACHEOSTOMY TRAY

View all 28 devices →

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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