SURGICAL SKIN MARKER— 510(k) K896792

Name: FDA 510(k) clearance K896792
Creator: U.S. Food and Drug Administration
Published: 1989-12-27

Substantially Equivalent

Westmark, Sterile Packing Systems, Inc. (Sps)

FDA 510(k) clearance K896792 for SURGICAL SKIN MARKER, Substantially Equivalent on 1989-12-27. Applicant: Westmark, Sterile Packing Systems, Inc. (Sps). Device class: 1.

Clearance details

Applicant: Westmark, Sterile Packing Systems, Inc. (Sps)
Product code: Code FZZ
Device class: Class 1
Regulation: 21 CFR 878.4660
Advisory panel: General, Plastic Surgery
Date received: 1989-12-01
Decision date: 1989-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FZZ

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K042555 — SURGICHIP TAG SURGICAL MARKER2004-11-09
K915066 — DISPOSABLE SKIN MARKER1992-05-14
K914759 — BLOOM TRANSPARENT STENCIL1992-04-21
K912730 — ROCKET SURGICAL SKIN MARKING PEN1991-11-07
K905143 — SKIN MARKER1991-02-06

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K896800 — IRRIGATION TRAY1990-05-24
K896799 — PARACERVICAL/PUDENDAL TRAYS1990-04-23
K896559 — INFANT FEEDING TUBE1990-03-13
K896794 — SPECIMEN CONTAINER1990-03-01
K896806 — CATHETER PLUG/PROTECTOR1990-02-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.