ENDOSCOPIC ANTI FOG DEVICE— 510(k) K993604

Substantially Equivalent

Mectra Labs, Inc.

FDA 510(k) clearance K993604 for ENDOSCOPIC ANTI FOG DEVICE, Substantially Equivalent on 2000-03-03. Applicant: Mectra Labs, Inc.. Device class: 2.

Clearance details

Applicant: Mectra Labs, Inc.
Product code: Code OCT
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1999-10-25
Decision date: 2000-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomfield, IN, 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.