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, eye sphere
510(k) Number K083342
Device Name ORBITAL RECONSTRUCTIVE IMPLANT II
Applicant
EVERA MEDICAL, INC.
353 VINTAGE PARK DRIVE
SUITE F
FOSTER CITY,  CA  94404
Applicant Contact RANDY KESTEN
Correspondent
EVERA MEDICAL, INC.
353 VINTAGE PARK DRIVE
SUITE F
FOSTER CITY,  CA  94404
Correspondent Contact RANDY KESTEN
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received11/12/2008
Decision Date 03/12/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-