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 And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K953450
Device Name CURASOL GEL WOUND DRESSING
Applicant
Dpt Laboratories, Ltd.
100 E. 15th St.,Suite 320
Fort Worth,  TX  76102
Applicant Contact RICHARD A HAMER
Correspondent
Dpt Laboratories, Ltd.
100 E. 15th St.,Suite 320
Fort Worth,  TX  76102
Correspondent Contact RICHARD A HAMER
Classification Product Code
MGQ  
Date Received07/18/1995
Decision Date 08/07/1995
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-