PARACERVICAL/PUDENDAL TRAYS— 510(k) K896799

Name: FDA 510(k) clearance K896799
Creator: U.S. Food and Drug Administration
Published: 1990-04-23

Substantially Equivalent

Westmark, Sterile Packing Systems, Inc. (Sps)

FDA 510(k) clearance K896799 for PARACERVICAL/PUDENDAL TRAYS, Substantially Equivalent on 1990-04-23. Applicant: Westmark, Sterile Packing Systems, Inc. (Sps). Device class: 2.

Clearance details

Applicant: Westmark, Sterile Packing Systems, Inc. (Sps)
Product code: Code CAZ
Device class: Class 2
Regulation: 21 CFR 868.5140
Advisory panel: Anesthesiology
Date received: 1989-12-01
Decision date: 1990-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

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K896800 — IRRIGATION TRAY1990-05-24
K896559 — INFANT FEEDING TUBE1990-03-13
K896794 — SPECIMEN CONTAINER1990-03-01
K896806 — CATHETER PLUG/PROTECTOR1990-02-26
K896798 — TRACHEOSTOMY TRAY1990-02-22

Adverse events under product code CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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