RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE— 510(k) K952187

Name: FDA 510(k) clearance K952187
Creator: U.S. Food and Drug Administration
Published: 1995-07-25

Substantially Equivalent

Rusch, Inc.

FDA 510(k) clearance K952187 for RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE, Substantially Equivalent on 1995-07-25. Applicant: Rusch, Inc.. Device class: 2.

Clearance details

Applicant: Rusch, Inc.
Product code: Code KOB
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1995-05-09
Decision date: 1995-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jeffrey, NH, 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.