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 K012619
Device Name VT-1
Applicant
Vts, Inc.
701 S. Main
Newkirk,  OK  74647
Applicant Contact DENNIS L BELL
Correspondent
Vts, Inc.
701 S. Main
Newkirk,  OK  74647
Correspondent Contact DENNIS L BELL
Regulation Number876.5020
Classification Product Code
LKY  
Date Received08/13/2001
Decision Date 11/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-