TUBALGATOR— 510(k) K113080

Substantially Equivalent

Mectra Labs, Inc.

FDA 510(k) clearance K113080 for TUBALGATOR, Substantially Equivalent on 2012-06-29. Applicant: Mectra Labs, Inc.. Device class: 2.

Clearance details

Applicant: Mectra Labs, Inc.
Product code: Code HIN
Device class: Class 2
Regulation: 21 CFR 884.4150
Advisory panel: Obstetrics/Gynecology
Date received: 2011-10-18
Decision date: 2012-06-29
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.