SEXTON CYSTOTOMY URINE PUMP— 510(k) K843158

Name: FDA 510(k) clearance K843158
Creator: U.S. Food and Drug Administration
Published: 1984-10-04

Substantially Equivalent

Holter-Hausner Intl.

FDA 510(k) clearance K843158 for SEXTON CYSTOTOMY URINE PUMP, Substantially Equivalent on 1984-10-04. Applicant: Holter-Hausner Intl.. Device class: 2.

Clearance details

Applicant: Holter-Hausner Intl.
Product code: Code KOB
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1984-08-10
Decision date: 1984-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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