E-Z-GUARD MOUTHPIECE— 510(k) K853402

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K853402 for E-Z-GUARD MOUTHPIECE, Substantially Equivalent on 1985-10-23. Applicant: E-Z-Em, Inc.. Device class: 1.

Clearance details

Applicant: E-Z-Em, Inc.
Product code: Code BYP
Device class: Class 1
Regulation: 21 CFR 868.5620
Advisory panel: Anesthesiology
Date received: 1985-08-12
Decision date: 1985-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westbury, NY, US

Download summary PDF View on FDA.gov ↗

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K053008 — E-Z-EM ENDOSCOPIC CO2 REGULATOR2005-12-27
K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725)2004-07-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.