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 Bandage, Liquid
510(k) Number K081009
Device Name NEUTROPHASE
Applicant
Novabay Pharmaceuticals
5980 Horton St. Suite 550
Emeryville,  CA  94608
Applicant Contact SHEILA W PICKERING
Correspondent
Novabay Pharmaceuticals
5980 Horton St. Suite 550
Emeryville,  CA  94608
Correspondent Contact SHEILA W PICKERING
Regulation Number880.5090
Classification Product Code
KMF  
Date Received04/08/2008
Decision Date 05/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-