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
510(k) Number K843559
Device Name KLEENIT BY QMED
Applicant
Qmed, Inc.
3001 W. Kentucky St.
Louisville,  KY  40211
Applicant Contact LARRY D POTTS
Correspondent
Qmed, Inc.
3001 W. Kentucky St.
Louisville,  KY  40211
Correspondent Contact LARRY D POTTS
Date Received09/10/1984
Decision Date 10/24/1984
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
-
-