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 prosthesis, penile
510(k) Number K896941
Device Name AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
11001 BREN RD. EAST
MINNETONKA,  MN  55343
Applicant Contact DENNIS TOUSSAINT
Correspondent
AMERICAN MEDICAL SYSTEMS, INC.
11001 BREN RD. EAST
MINNETONKA,  MN  55343
Correspondent Contact DENNIS TOUSSAINT
Regulation Number876.3630
Classification Product Code
FAE  
Date Received12/13/1989
Decision Date 03/06/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-