STAYEREC SYSTEM(TM)— 510(k) K901318

Name: FDA 510(k) clearance K901318
Creator: U.S. Food and Drug Administration
Published: 1990-05-04

Substantially Equivalent

Osbon Medical Systems, Ltd.

FDA 510(k) clearance K901318 for STAYEREC SYSTEM(TM), Substantially Equivalent on 1990-05-04. Applicant: Osbon Medical Systems, Ltd.. Device class: 2.

Clearance details

Applicant: Osbon Medical Systems, Ltd.
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1990-03-21
Decision date: 1990-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Augusta, GA, US

Download summary PDF View on FDA.gov ↗

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