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 Tissue Expander And Accessories
510(k) Number K142998
Device Name CPX Control Breast Tissue Expander
Applicant
Mentor Worldwide, LLC
201 Mentor Dr.
Santa Barbara,  CA  93111
Applicant Contact Manchi Cheung
Correspondent
Mentor Worldwide, LLC
201 Mentor Dr.
Santa Barbara,  CA  93111
Correspondent Contact Manchi Cheung
Classification Product Code
LCJ  
Date Received10/17/2014
Decision Date 12/19/2014
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
-
-