ENDOMARK STERILE INDIA INK— 510(k) K042901

Substantially Equivalent

Pmt Corp.

FDA 510(k) clearance K042901 for ENDOMARK STERILE INDIA INK, Substantially Equivalent on 2005-03-16. Applicant: Pmt Corp.. Device class: 2.

Clearance details

Applicant: Pmt Corp.
Product code: Code NBG
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2004-10-20
Decision date: 2005-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chanhassen, 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.