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 Cleanser, Root Canal
510(k) Number K141352
Device Name ENDOCYN ROOT CANAL IRRIGATION SOLUTION
Applicant
Oculus Innovative Sciences
1129 N. Mcdowell Blvd.
Petaluma,  CA  94954
Applicant Contact BRIAN W MARTIN
Correspondent
Oculus Innovative Sciences
1129 N. Mcdowell Blvd.
Petaluma,  CA  94954
Correspondent Contact BRIAN W MARTIN
Classification Product Code
KJJ  
Date Received05/23/2014
Decision Date 08/18/2014
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-