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 dilator, esophageal
510(k) Number K090183
Device Name HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
Applicant
COOK ENDOSCOPY
4900 BETHANIA STATION RD.
WINSTON-SALEM,  NC  27105
Applicant Contact TIFFANNY THOMAS
Correspondent
COOK ENDOSCOPY
4900 BETHANIA STATION RD.
WINSTON-SALEM,  NC  27105
Correspondent Contact TIFFANNY THOMAS
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received01/26/2009
Decision Date 09/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-