ENDOSCOPIC MANUAL AIR INSUFFLATOR— 510(k) K844689

Name: FDA 510(k) clearance K844689
Creator: U.S. Food and Drug Administration
Published: 1985-01-02

Substantially Equivalent

Jayco Pharmaceuticals

FDA 510(k) clearance K844689 for ENDOSCOPIC MANUAL AIR INSUFFLATOR, Substantially Equivalent on 1985-01-02. Applicant: Jayco Pharmaceuticals. Device class: 2.

Clearance details

Applicant: Jayco Pharmaceuticals
Product code: Code FCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1984-12-03
Decision date: 1985-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camp Hill, PA, US

Download summary PDF View on FDA.gov ↗

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