• 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 K854794
Device Name MCGHAN INTEGRAL VALVE TISSUE EXPANDER
Applicant
Mcghan Medical Corp.
700 Ward Dr.
Santa Barbara,  CA  93111
Applicant Contact LAURENS LICHTY
Correspondent
Mcghan Medical Corp.
700 Ward Dr.
Santa Barbara,  CA  93111
Correspondent Contact LAURENS LICHTY
Classification Product Code
LCJ  
Date Received12/02/1985
Decision Date 12/24/1985
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
-
-