FDA.reportPublic FDA data

510(k) K854361

Device
Co2 Laser Laparoscope System
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
510(k) number
K854361
Product code
HHR
Decision
Substantially Equivalent (SESE)
Decision date
1986-02-04
Date received
1985-10-29
Regulation
884.4550
Classification name
Laser, Surgical, Gynecologic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CHARLES P GILL
Address
7046 Lyndon Ave. Rosemont IL US 60018 60018

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HHR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881507ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIESHgm Medical Laser Systems, Inc.1989-04-27
K871875MODEL 5050 SURGILASER FOR OB-GYN USELasermatic, Inc.1988-08-22
K875314GL-35 COLPOSCOPIC LASER SYSTEMLaser Engineering, Inc.1988-08-05
K874615LASER CANNISTER FILTERMedical Marketing, Inc.1988-06-23
K880591LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USELaser Peripherals, LLC1988-06-01
K880930MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASECopper Lasersonics, Inc.1988-05-31
K880991LASER OPTICAL CATHETER SYSTEMMedline Industries, Inc.1988-05-25
K880173MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATIONCooper Lasersonics, Inc.1988-03-24
K874837KTP/532 LASER FOR OB-GYN USELaserscope1988-03-14
K875078HERACURE LS 500W.C. Heraeus GmbH1988-02-22
K872709MODEL 20-C, RL-20A/U, OB-10A/UDirected Energy, Inc.1988-02-02
K870841MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYNDirected Energy, Inc.1988-02-02
K864946ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USEBio Quantum Technologies, Inc.1988-01-28
K872352FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIALaser Media1987-12-30
K872254SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITALSurgical Laser Technologies, Inc.1987-12-14