SANG-A PETROLATUM GAUZE USP STERILE— 510(k) K843035

Name: FDA 510(k) clearance K843035
Creator: U.S. Food and Drug Administration
Published: 1984-09-20

Substantially Equivalent

Tech-Cons Ltd., Intl.

FDA 510(k) clearance K843035 for SANG-A PETROLATUM GAUZE USP STERILE, Substantially Equivalent on 1984-09-20. Applicant: Tech-Cons Ltd., Intl.. Device class: Unclassified.

Clearance details

Applicant: Tech-Cons Ltd., Intl.
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 1984-08-02
Decision date: 1984-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K843117 — GREEN CROSS URINARY DRAINAGE BAG1984-10-11
K842228 — AIMED FOLEY CATHETER VARIOUS SIZES1984-09-10
K842230 — AIMED DISPOS. INJECTION NEEDLE1984-08-17
K842255 — AIMED SCALP VEIN SET VARIOUS1984-08-17
K842227 — AIMED DISPOSABLE SYRINGE, VARIOUS SIZES1984-07-23

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.