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, External Penile Rigidity
510(k) Number K962915
Device Name ACTIS (VENOUS FLOW CONTROLLER)
Applicant
Vivus, Inc.
545 Middlefield Rd., Suite 200
Menlo Park,  CA  94025
Applicant Contact NEIL GESUNDHEIT, M.D.
Correspondent
Vivus, Inc.
545 Middlefield Rd., Suite 200
Menlo Park,  CA  94025
Correspondent Contact NEIL GESUNDHEIT, M.D.
Regulation Number876.5020
Classification Product Code
LKY  
Date Received07/26/1996
Decision Date 12/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-