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 colonoscope and accessories, flexible/rigid
510(k) Number K093187
Device Name MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
Applicant
AVANTIS MEDICAL SYSTEMS, INC.
263 SANTA ANA CT.
SUNNYVALE,  CA  94085
Applicant Contact ELAINE APLAON
Correspondent
AVANTIS MEDICAL SYSTEMS, INC.
263 SANTA ANA CT.
SUNNYVALE,  CA  94085
Correspondent Contact ELAINE APLAON
Regulation Number876.1500
Classification Product Code
FDF  
Date Received10/09/2009
Decision Date 11/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-