• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name dilator, esophageal
510(k) Number K851955
Device Name SAVARY-GILLIARD DILATOR
Original Applicant
WILSON-COOK MEDICAL, INC.
4900 bethania station rd.
winston-salem,  NC  27105
Original Contact jon wilson
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received05/03/1985
Decision Date 07/25/1985
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-