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 K010902
Device Name MEDPOR QUAD MOTILITY IMPLANT
Applicant
Porex Surgical, Inc.
15 Dart Rd.
Newnan,  GA  30265
Applicant Contact HOWARD MERCER
Correspondent
Porex Surgical, Inc.
15 Dart Rd.
Newnan,  GA  30265
Correspondent Contact HOWARD MERCER
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received03/26/2001
Decision Date 06/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-