MODEL 20-C, RL-20A/U, OB-10A/U— 510(k) K872709

Name: FDA 510(k) clearance K872709
Creator: U.S. Food and Drug Administration
Published: 1988-02-02

Substantially Equivalent

Directed Energy, Inc.

FDA 510(k) clearance K872709 for MODEL 20-C, RL-20A/U, OB-10A/U, Substantially Equivalent on 1988-02-02. Applicant: Directed Energy, Inc.. Device class: 2.

Clearance details

Applicant: Directed Energy, Inc.
Product code: Code HHR
Device class: Class 2
Regulation: 21 CFR 884.4550
Advisory panel: Obstetrics/Gynecology
Date received: 1987-07-07
Decision date: 1988-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HHR

view all

K881507 — ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES1989-04-27
K871875 — MODEL 5050 SURGILASER FOR OB-GYN USE1988-08-22
K875314 — GL-35 COLPOSCOPIC LASER SYSTEM1988-08-05
K874615 — LASER CANNISTER FILTER1988-06-23
K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE1988-06-01

More clearances from Directed Energy, Inc.

view all

K904930 — SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH1991-03-21
K894241 — MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT1990-06-18
K883738 — CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.1988-11-15
K882926 — MODEL AU-1 ACCESSORY UNIT1988-09-09
K880216 — MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.1988-03-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.