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 Dressing, Wound, Drug
510(k) Number K102945
Device Name PEDIACYN ATOPIC DERMATITIS HYDROGEL
Applicant
Oculus Innovative Sciences, Inc.
1135 N. Mc Dowell Blvd.
Petaluma,  CA  94954
Applicant Contact ANTOINETTE DOUGLAS
Correspondent
Oculus Innovative Sciences, Inc.
1135 N. Mc Dowell Blvd.
Petaluma,  CA  94954
Correspondent Contact ANTOINETTE DOUGLAS
Classification Product Code
FRO  
Date Received10/04/2010
Decision Date 02/02/2011
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-