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 Lens, Contact, Polymethylmethacrylate, Diagnostic
510(k) Number K050623
Device Name VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
Applicant
Volk Optical, Inc.
15825 Shady Grove Rd.Suite 30
Rockville,  MD  20850
Applicant Contact RICHARD E LIPPMAN
Correspondent
Volk Optical, Inc.
15825 Shady Grove Rd.Suite 30
Rockville,  MD  20850
Correspondent Contact RICHARD E LIPPMAN
Regulation Number886.1385
Classification Product Code
HJK  
Date Received03/10/2005
Decision Date 03/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-