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 System, Suction, Lipoplasty
510(k) Number K083455
Device Name LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100
Applicant
Medi-Khan USA, Inc.
1516 Oak St.,
Suite 312
Alameda,  CA  94501
Applicant Contact JULIE SANTIAGO
Correspondent
Medi-Khan USA, Inc.
1516 Oak St.,
Suite 312
Alameda,  CA  94501
Correspondent Contact JULIE SANTIAGO
Regulation Number878.5040
Classification Product Code
MUU  
Date Received11/21/2008
Decision Date 05/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-