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 instrument, vitreous aspiration and cutting, ac-powered
510(k) Number K120170
Device Name PROCARE PLUS VITRECTOMY SYSTEM
Applicant
VISIONCARE DEVICES, INC.
1246 REDWOOD BLVD.
REDDING,  CA  96003
Applicant Contact KURTIS MONTEGNA
Correspondent
VISIONCARE DEVICES, INC.
1246 REDWOOD BLVD.
REDDING,  CA  96003
Correspondent Contact KURTIS MONTEGNA
Regulation Number886.4150
Classification Product Code
HQE  
Date Received01/19/2012
Decision Date 05/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-