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510(k) K984521

Device
RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
510(k) number
K984521
Product code
EQL  
Decision
Substantially Equivalent (SESE)
Decision date
1999-03-17
Date received
1998-12-21
Regulation
874.4750
Classification name
Laryngostroboscope
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROBERT L CASARSA
Address
353 Corporate Woods Pkwy. Vernon Hills IL US 60061 60061

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EQL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K921184RLS 9100 RHINO-LARYNGEAL STROBOSCOPEKay Elemetrics Corp.1992-05-28
K9212859105 RIGID TELESCOPIC ENDOSCOPEKay Elemetrics Corp.1992-05-28
K884933ENDOSTROBOSCOPE IVJedmed Instrument Co.1989-02-15
K842090RHINO-LARYNX STROBOSCOPE TYPE 4914Bruel & Kjaer Industri A/S1984-07-18
K822523LARYNGOSTROBOSCOPEKelleher Corp.1982-09-09
K801866PENTAX LARYNGO-STROBOSCOPE MODEL LS-1APentax Precision Instrument Corp.1980-09-16
K770466STOCKINGS, RVS TMParke-Davis Co.1977-03-28

Legacy Summary#

summary

FDA Review#

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