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 K053298
Device Name ALPHASPHERE ORBITAL IMPLANT
Applicant
Hydron Pty Limited
733 Bolsana Dr.
Laguna Beach,  CA  92651
Applicant Contact JUDY F GORDON
Correspondent
Hydron Pty Limited
733 Bolsana Dr.
Laguna Beach,  CA  92651
Correspondent Contact JUDY F GORDON
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received11/25/2005
Decision Date 05/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-