ANCHORAGE ACCESS KIT— 510(k) K073507

Substantially Equivalent

Epitek, Inc.

FDA 510(k) clearance K073507 for ANCHORAGE ACCESS KIT, Substantially Equivalent on 2008-03-05. Applicant: Epitek, Inc.. Device class: 2.

Clearance details

Applicant: Epitek, Inc.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2007-12-13
Decision date: 2008-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, MN, 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.