ERECAID(R) SYSTEM PLUS— 510(k) K912736

Name: FDA 510(k) clearance K912736
Creator: U.S. Food and Drug Administration
Published: 1991-08-12

Substantially Equivalent

Osbon Medical Systems, Ltd.

FDA 510(k) clearance K912736 for ERECAID(R) SYSTEM PLUS, Substantially Equivalent on 1991-08-12. 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: 1991-06-21
Decision date: 1991-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Augusta, GA, US

Download summary PDF View on FDA.gov ↗

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