• 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 sigmoidoscope and accessories, flexible/rigid
510(k) Number K964326
Device Name VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM
Applicant
VISION-SCIENCES, INC.
6 STRATHMORE RD.
NATICK,  MA  01760
Applicant Contact PAMELA PAPINEAU
Correspondent
VISION-SCIENCES, INC.
6 STRATHMORE RD.
NATICK,  MA  01760
Correspondent Contact PAMELA PAPINEAU
Regulation Number876.1500
Classification Product Code
FAM  
Date Received10/30/1996
Decision Date 01/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-