GL-35 COLPOSCOPIC LASER SYSTEM— 510(k) K875314

Name: FDA 510(k) clearance K875314
Creator: U.S. Food and Drug Administration
Published: 1988-08-05

Substantially Equivalent

Laser Engineering, Inc.

FDA 510(k) clearance K875314 for GL-35 COLPOSCOPIC LASER SYSTEM, Substantially Equivalent on 1988-08-05. Applicant: Laser Engineering, Inc.. Device class: 2.

Clearance details

Applicant: Laser Engineering, Inc.
Product code: Code HHR
Device class: Class 2
Regulation: 21 CFR 884.4550
Advisory panel: Obstetrics/Gynecology
Date received: 1987-12-29
Decision date: 1988-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, MA, US

Download summary PDF View on FDA.gov ↗

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