VTU-E VACUUM ERECTION SYSTEM— 510(k) K974470

Substantially Equivalent

Encore, Inc.

FDA 510(k) clearance K974470 for VTU-E VACUUM ERECTION SYSTEM, Substantially Equivalent on 1998-01-09. Applicant: Encore, Inc.. Device class: 2.

Clearance details

Applicant: Encore, Inc.
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1997-11-26
Decision date: 1998-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.