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 Device, Cystometric, Hydraulic
510(k) Number K922776
Device Name FST COUNCIL TIP FOLEY CATHETER
Applicant
FIBEROPTIC SENSOR TECHNLOGIES, INC.
501 AVIS DR.
ANN ARBOR,  MI  48108
Applicant Contact MICHAEL D COLLIVER
Correspondent
FIBEROPTIC SENSOR TECHNLOGIES, INC.
501 AVIS DR.
ANN ARBOR,  MI  48108
Correspondent Contact MICHAEL D COLLIVER
Regulation Number876.1620
Classification Product Code
FEN  
Date Received06/09/1992
Decision Date 07/20/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-