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 Oral Wound Dressing
510(k) Number K062795
Device Name MUGARD MUCOADHESIVE ORAL WOUND RINSE
Applicant
ACCESS PHARMACEUTICALS, INC
2600 STEMMONS FREEWAY
SUITE 176
DALLAS,  TX  75207
Applicant Contact DAVID NOWOTNIK, PH.D.
Correspondent
ACCESS PHARMACEUTICALS, INC
2600 STEMMONS FREEWAY
SUITE 176
DALLAS,  TX  75207
Correspondent Contact DAVID NOWOTNIK, PH.D.
Classification Product Code
OLR  
Date Received09/18/2006
Decision Date 12/11/2006
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
-
-