NES REPROCESSED ENDOSCOPIC TROCAR— 510(k) K060676

Name: FDA 510(k) clearance K060676
Creator: U.S. Food and Drug Administration
Published: 2007-09-07

Substantially Equivalent

Northeast Scientific, Inc.

FDA 510(k) clearance K060676 for NES REPROCESSED ENDOSCOPIC TROCAR, Substantially Equivalent on 2007-09-07. Applicant: Northeast Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Northeast Scientific, Inc.
Product code: Code NLM
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2006-03-14
Decision date: 2007-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waterbury, CT, 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.