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 hemorrhoid prevention pressure wedge
De Novo Number DEN090011
510(K) Number K083692
Device Name HEM-AVERT PERIANAL STABILIZER
Requester
PLEXUS BIOMEDICAL INC.
70 clay street
suite 2
oakland,  TN  38060
Contact david blurton
Regulation Number884.5200
Classification Product Code
OOA  
Date Received08/18/2009
Decision Date 01/13/2011
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
-
-