ENTREE CANNULA FASCIA ANCHORS— 510(k) K932021

Name: FDA 510(k) clearance K932021
Creator: U.S. Food and Drug Administration
Published: 1994-01-11

Substantially Equivalent

Core Dynamics, Inc.

FDA 510(k) clearance K932021 for ENTREE CANNULA FASCIA ANCHORS, Substantially Equivalent on 1994-01-11. Applicant: Core Dynamics, Inc.. Device class: 1.

Clearance details

Applicant: Core Dynamics, Inc.
Product code: Code FBM
Device class: Class 1
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1993-04-23
Decision date: 1994-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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