• 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 negative pressure wound therapy non-powered suction apparatus
De Novo Number DEN080011
510(K) Number K081406
Device Name SNAP WOUND CARE DEVICE
Requester
spiracur, inc.
1835 market street
suite 2820
philadelphia,  PA  19103
Contact janice m hogan
Regulation Number878.4683
Classification Product Code
OKO  
Date Received11/03/2008
Decision Date 08/07/2009
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
Type Post-NSE
-
-