PAEDIATRIC FACE MASK 1-3 W/WO RING— 510(k) K834454

Name: FDA 510(k) clearance K834454
Creator: U.S. Food and Drug Administration
Published: 1984-01-18

Substantially Equivalent

Warne Surgical Products, Ltd.

FDA 510(k) clearance K834454 for PAEDIATRIC FACE MASK 1-3 W/WO RING, Substantially Equivalent on 1984-01-18. Applicant: Warne Surgical Products, Ltd.. Device class: 1.

Clearance details

Applicant: Warne Surgical Products, Ltd.
Product code: Code BSJ
Device class: Class 1
Regulation: 21 CFR 868.5550
Advisory panel: Anesthesiology
Date received: 1983-12-19
Decision date: 1984-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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