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 Implant, Malar
510(k) Number K934233
Device Name ZARA ZONE IV MALAR IMPLANT MODIFICATION
Applicant
Byron Medical
3280 E. Hemisphere Loop
Suite 100
Tucson,  AZ  85706
Applicant Contact BYRON ECONOMIDY
Correspondent
Byron Medical
3280 E. Hemisphere Loop
Suite 100
Tucson,  AZ  85706
Correspondent Contact BYRON ECONOMIDY
Regulation Number878.3550
Classification Product Code
LZK  
Date Received08/30/1993
Decision Date 02/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-