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
Predetermined Change
Control Plan Authorized		 No
-
-