SPECULUM, VAGINAL, METAL FIBEROPTIC— 510(k) K864865

Name: FDA 510(k) clearance K864865
Creator: U.S. Food and Drug Administration
Published: 1987-01-09

Substantially Equivalent

Luxtec Corp.

FDA 510(k) clearance K864865 for SPECULUM, VAGINAL, METAL FIBEROPTIC, Substantially Equivalent on 1987-01-09. Applicant: Luxtec Corp.. Device class: 1.

Clearance details

Applicant: Luxtec Corp.
Product code: Code HDG
Device class: Class 1
Regulation: 21 CFR 884.4520
Advisory panel: Obstetrics/Gynecology
Date received: 1986-12-11
Decision date: 1987-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sturbridge, MA, 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.