DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)— 510(k) K980863

Name: FDA 510(k) clearance K980863
Creator: U.S. Food and Drug Administration
Published: 1998-05-11

Substantially Equivalent

Dumex Medical Surgical Products, Ltd.

FDA 510(k) clearance K980863 for DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC), Substantially Equivalent on 1998-05-11. Applicant: Dumex Medical Surgical Products, Ltd.. Device class: 1.

Clearance details

Applicant: Dumex Medical Surgical Products, Ltd.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1998-03-05
Decision date: 1998-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Orntario, CA

Download summary PDF View on FDA.gov ↗

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