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 nasopharyngoscope (flexible or rigid)
510(k) Number K945081
Device Name TRANSTYMPANIC ENDOSCOPE
Applicant
ENDO OPTIKS, INC.
39 SYCAMORE AVE.
LITTLE SILVER,  NJ  07739 -1208
Applicant Contact JIM OHNECK
Correspondent
ENDO OPTIKS, INC.
39 SYCAMORE AVE.
LITTLE SILVER,  NJ  07739 -1208
Correspondent Contact JIM OHNECK
Regulation Number874.4760
Classification Product Code
EOB  
Date Received10/17/1994
Decision Date 03/06/1995
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
-
-