WSP CODE 4310 STRESSCATH— 510(k) K850694

Name: FDA 510(k) clearance K850694
Creator: U.S. Food and Drug Administration
Published: 1985-05-17

Substantially Equivalent

Warne Surgical Products, Ltd.

FDA 510(k) clearance K850694 for WSP CODE 4310 STRESSCATH, Substantially Equivalent on 1985-05-17. Applicant: Warne Surgical Products, Ltd.. Device class: 2.

Clearance details

Applicant: Warne Surgical Products, Ltd.
Product code: Code FAP
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1985-02-21
Decision date: 1985-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Armagh Bt66 8rd, IE

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