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 K940414
Device Name IODOFLEX PASTE
Applicant
OCLASSEN PHARMACEUTICALS, INC.
100 PELICAN WAY
SAN RAFAEL,  CA  94901
Applicant Contact ROSS J DILEO
Correspondent
OCLASSEN PHARMACEUTICALS, INC.
100 PELICAN WAY
SAN RAFAEL,  CA  94901
Correspondent Contact ROSS J DILEO
Regulation Number880.5090
Classification Product Code
KMF  
Date Received01/28/1994
Decision Date 04/28/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-