STERILE CENTRAL LINE DRESSING TRAY— 510(k) K934031

Name: FDA 510(k) clearance K934031
Creator: U.S. Food and Drug Administration
Published: 1994-03-01

Unknown

Surgipro, Inc.

FDA 510(k) clearance K934031 for STERILE CENTRAL LINE DRESSING TRAY, Unknown on 1994-03-01. Applicant: Surgipro, Inc.. Device class: 2.

Clearance details

Applicant: Surgipro, Inc.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1993-08-17
Decision date: 1994-03-01
Decision: Unknown
Clearance type: Traditional
Location: Palm Florida, FL, US

Download summary PDF View on FDA.gov ↗

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K934030 — STERILE TRACHEOSTOMY TRAY1994-01-26
K912351 — VARIOUS STERILE CUSTOM DRESSING TRAYS & KITS1993-06-17

Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.