NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR— 510(k) K952824

Name: FDA 510(k) clearance K952824
Creator: U.S. Food and Drug Administration
Published: 1995-07-20

Substantially Equivalent

Intertex Medical, Inc.

FDA 510(k) clearance K952824 for NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR, Substantially Equivalent on 1995-07-20. Applicant: Intertex Medical, Inc.. Device class: 1.

Clearance details

Applicant: Intertex Medical, Inc.
Product code: Code BZA
Device class: Class 1
Regulation: 21 CFR 868.5810
Advisory panel: Anesthesiology
Date received: 1995-06-20
Decision date: 1995-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Canaan, CT, US

Download summary PDF View on FDA.gov ↗

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