MODEL GLASE 210 HOLMIUM LASER SYSTEM— 510(k) K904248

Name: FDA 510(k) clearance K904248
Creator: U.S. Food and Drug Administration
Published: 1990-12-14

Substantially Equivalent

Charles L. Rose and Co., Inc.

FDA 510(k) clearance K904248 for MODEL GLASE 210 HOLMIUM LASER SYSTEM, Substantially Equivalent on 1990-12-14. Applicant: Charles L. Rose and Co., Inc.. Device class: 2.

Clearance details

Applicant: Charles L. Rose and Co., Inc.
Product code: Code HGF
Device class: Class 2
Regulation: 21 CFR 884.5070
Advisory panel: Obstetrics/Gynecology
Date received: 1990-09-17
Decision date: 1990-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, 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.