• 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 K011869
Device Name XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
Applicant
THE OLYMPUS OPTICAL CO.
TWO CORPORATE DR.
MELVILLE,  NY  11747
Applicant Contact LAURA STORMS-TYLER
Correspondent
THE OLYMPUS OPTICAL CO.
TWO CORPORATE DR.
MELVILLE,  NY  11747
Correspondent Contact LAURA STORMS-TYLER
Regulation Number874.4760
Classification Product Code
EOB  
Date Received06/14/2001
Decision Date 07/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-