• 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 K082667
Device Name VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)
Applicant
VISIONSENSE, LTD.
555 13TH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact GERARD J PRUD'HOMME
Correspondent
VISIONSENSE, LTD.
555 13TH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact GERARD J PRUD'HOMME
Regulation Number874.4760
Classification Product Code
EOB  
Date Received09/12/2008
Decision Date 10/30/2008
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
-
-