CYCLER W/5 OR 10 HR. FILL/DWELL TIMER— 510(k) K800496

Name: FDA 510(k) clearance K800496
Creator: U.S. Food and Drug Administration
Published: 1980-07-21

Substantially Equivalent

American Medical Products, Inc.

FDA 510(k) clearance K800496 for CYCLER W/5 OR 10 HR. FILL/DWELL TIMER, Substantially Equivalent on 1980-07-21. Applicant: American Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: American Medical Products, Inc.
Product code: Code KPF
Device class: Class 2
Regulation: 21 CFR 876.5630
Advisory panel: Gastroenterology, Urology
Date received: 1980-03-04
Decision date: 1980-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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