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 K012543
Device Name VISION SCIENCES ENDOSHEATH SYSTEM
Applicant
VISION-SCIENCES, INC.
5 WHITCOMB AVE.
AYER,  MA  01432
Applicant Contact PAMELA PAPINEU
Correspondent
VISION-SCIENCES, INC.
5 WHITCOMB AVE.
AYER,  MA  01432
Correspondent Contact PAMELA PAPINEU
Regulation Number874.4760
Classification Product Code
EOB  
Date Received08/07/2001
Decision Date 07/15/2002
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
-
-