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

Device Classification Under Section 513(f)(2)(De Novo)
  • 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 vibrator for climax control of premature ejaculation
De Novo Number DEN130047
Device Name PROLONG
Requester
ERGON MEDICAL LTD.
25 barker close
fishbourne, chichester
west sussex,  GB po18 8bj
Contact barry pearce
Regulation Number876.5025
Classification Product Code
PIA  
Date Received11/18/2013
Decision Date 03/20/2015
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
-
-