AMNIGLOVE & AMNICOT— 510(k) K850758

Name: FDA 510(k) clearance K850758
Creator: U.S. Food and Drug Administration
Published: 1985-04-15

Substantially Equivalent

Go Medical Industries Pty. , Ltd.

FDA 510(k) clearance K850758 for AMNIGLOVE & AMNICOT, Substantially Equivalent on 1985-04-15. Applicant: Go Medical Industries Pty. , Ltd.. Device class: 1.

Clearance details

Applicant: Go Medical Industries Pty. , Ltd.
Product code: Code HGE
Device class: Class 1
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1985-02-25
Decision date: 1985-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Western Australia, AU

Download summary PDF View on FDA.gov ↗

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