DETRUSAN 500— 510(k) K994109

Substantially Equivalent

Innovamed USA, Inc.

FDA 510(k) clearance K994109 for DETRUSAN 500, Substantially Equivalent on 2000-08-03. Applicant: Innovamed USA, Inc..

Clearance details

Applicant: Innovamed USA, Inc.
Product code: Code KPI
Advisory panel: Gastroenterology, Urology
Date received: 1999-12-06
Decision date: 2000-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lehigh Acres, FL, US

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