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
-
-