CO2 LASER MICROMANIPULATOR— 510(k) K864378

Name: FDA 510(k) clearance K864378
Creator: U.S. Food and Drug Administration
Published: 1987-03-05

Substantially Equivalent

Transamerican Technologies Intl.

FDA 510(k) clearance K864378 for CO2 LASER MICROMANIPULATOR, Substantially Equivalent on 1987-03-05. Applicant: Transamerican Technologies Intl.. Device class: 2.

Clearance details

Applicant: Transamerican Technologies Intl.
Product code: Code HHR
Device class: Class 2
Regulation: 21 CFR 884.4550
Advisory panel: Obstetrics/Gynecology
Date received: 1986-11-05
Decision date: 1987-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette, CA, US

Download summary PDF View on FDA.gov ↗

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