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 K943470
Device Name BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTS
Applicant
Levtrade Intl. (Pty) , Ltd.
22 Central St.
P.O. Box 150
Kingham,  MA  02043
Applicant Contact WILLIAM M KOPLOVSKY
Correspondent
Levtrade Intl. (Pty) , Ltd.
22 Central St.
P.O. Box 150
Kingham,  MA  02043
Correspondent Contact WILLIAM M KOPLOVSKY
Classification Product Code
MGQ  
Date Received07/19/1994
Decision Date 09/27/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-