PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL— 510(k) K934585

Name: FDA 510(k) clearance K934585
Creator: U.S. Food and Drug Administration
Published: 1993-11-03

Substantially Equivalent

Lafayette Pharmaceuticals, Inc.

FDA 510(k) clearance K934585 for PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL, Substantially Equivalent on 1993-11-03. Applicant: Lafayette Pharmaceuticals, Inc.. Device class: 1.

Clearance details

Applicant: Lafayette Pharmaceuticals, Inc.
Product code: Code FCD
Device class: Class 1
Regulation: 21 CFR 876.5210
Advisory panel: Gastroenterology, Urology
Date received: 1993-09-23
Decision date: 1993-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette, IN, US

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