MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM— 510(k) K895643

Name: FDA 510(k) clearance K895643
Creator: U.S. Food and Drug Administration
Published: 1989-10-17

Substantially Equivalent

Orthoconcept, Inc.

FDA 510(k) clearance K895643 for MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM, Substantially Equivalent on 1989-10-17. Applicant: Orthoconcept, Inc.. Device class: 2.

Clearance details

Applicant: Orthoconcept, Inc.
Product code: Code FDC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1989-08-28
Decision date: 1989-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, SC, US

Download summary PDF View on FDA.gov ↗

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