Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Source, Carrier, Fiberoptic Light
510(k) Number K923774
Device Name DISPOSABLE ENDOILLUMINATOR
Applicant
O.R. SPECIALTIES, INC.
4749 APPLETREE LN.
TUSCALOOSA,  AL  35405
Applicant Contact JACK W HOWARD
Correspondent
O.R. SPECIALTIES, INC.
4749 APPLETREE LN.
TUSCALOOSA,  AL  35405
Correspondent Contact JACK W HOWARD
Regulation Number874.4350
Classification Product Code
EQH  
Date Received07/28/1992
Decision Date 10/19/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-