• 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 bronchoscope (flexible or rigid)
510(k) Number K963795
Device Name VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH
Applicant
VISION-SCIENCES, INC.
6 STRATHMORE RD.
NATICK,  MA  01760
Applicant Contact PAMELA L PAPINEAU
Correspondent
VISION-SCIENCES, INC.
6 STRATHMORE RD.
NATICK,  MA  01760
Correspondent Contact PAMELA L PAPINEAU
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received09/23/1996
Decision Date 12/23/1996
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
-
-