RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET— 510(k) K963993

Name: FDA 510(k) clearance K963993
Creator: U.S. Food and Drug Administration
Published: 1996-12-17

Substantially Equivalent

Rusch, Inc.

FDA 510(k) clearance K963993 for RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET, Substantially Equivalent on 1996-12-17. Applicant: Rusch, Inc.. Device class: 2.

Clearance details

Applicant: Rusch, Inc.
Product code: Code FCM
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1996-10-04
Decision date: 1996-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jeffrey, NH, US

Download summary PDF View on FDA.gov ↗

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