LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE— 510(k) K880591

Name: FDA 510(k) clearance K880591
Creator: U.S. Food and Drug Administration
Published: 1988-06-01

Substantially Equivalent

Laser Peripherals, LLC

FDA 510(k) clearance K880591 for LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE, Substantially Equivalent on 1988-06-01. Applicant: Laser Peripherals, LLC. Device class: 2.

Clearance details

Applicant: Laser Peripherals, LLC
Product code: Code HHR
Device class: Class 2
Regulation: 21 CFR 884.4550
Advisory panel: Obstetrics/Gynecology
Date received: 1988-02-11
Decision date: 1988-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hingham, 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.