Seal Rite Non-Rebreathing Valve— 510(k) K152521

Name: FDA 510(k) clearance K152521
Creator: U.S. Food and Drug Administration
Published: 2016-06-03

Substantially Equivalent

The Lifeguard Store, Inc.

FDA 510(k) clearance K152521 for Seal Rite Non-Rebreathing Valve, Substantially Equivalent on 2016-06-03. Applicant: The Lifeguard Store, Inc.. Device class: 2.

Clearance details

Applicant: The Lifeguard Store, Inc.
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 2015-09-03
Decision date: 2016-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Normal, IL, US

Download summary PDF View on FDA.gov ↗

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