PROD. NO. 02-031 - LACERATION TRAY— 510(k) K963443

Name: FDA 510(k) clearance K963443
Creator: U.S. Food and Drug Administration
Published: 1996-10-17

Substantially Equivalent

Continental Medical Laboratories, Inc.

FDA 510(k) clearance K963443 for PROD. NO. 02-031 - LACERATION TRAY, Substantially Equivalent on 1996-10-17. Applicant: Continental Medical Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Continental Medical Laboratories, Inc.
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1996-08-30
Decision date: 1996-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waterford, WI, US

Download summary PDF View on FDA.gov ↗

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K964827 — PROD. NO. 01-132 - SUTURE REMOVAL KIT1997-02-14
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K962078 — TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER1996-10-11
K954728 — PROD NO. 01-1694 - 4X4 FOAM DRESSING1996-09-23
K962073 — URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY1996-06-21

Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.