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 Replacer, Urethral
510(k) Number K833690
Device Name COAXIAL BALLOON URETHRAL DILATOR
Applicant
American Edwards Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Edwards Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Classification Product Code
FAA  
Date Received10/18/1983
Decision Date 11/29/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-