WATERS ILEAL RESERVOIR CATHETER— 510(k) K813494

Name: FDA 510(k) clearance K813494
Creator: U.S. Food and Drug Administration
Published: 1981-12-31

Substantially Equivalent

Waters Instruments, Inc.

FDA 510(k) clearance K813494 for WATERS ILEAL RESERVOIR CATHETER, Substantially Equivalent on 1981-12-31. Applicant: Waters Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Waters Instruments, Inc.
Product code: Code KPH
Device class: Class 1
Regulation: 21 CFR 876.5030
Advisory panel: Gastroenterology, Urology
Date received: 1981-12-14
Decision date: 1981-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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