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 prosthesis, eyelid spacer/graft, biologic
510(k) Number K053622
Device Name SURGISIS OCULAR GRAFT
Applicant
IOP, INC.
3184 AIRWAY AVE., BLDG. B
COSTA MESA,  CA  92626
Applicant Contact JASON MALECKA
Correspondent
IOP, INC.
3184 AIRWAY AVE., BLDG. B
COSTA MESA,  CA  92626
Correspondent Contact JASON MALECKA
Regulation Number886.3130
Classification Product Code
NXM  
Date Received12/28/2005
Decision Date 03/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-