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 K871871
Device Name SERIES TEN THOUSAND OCUTOME
Applicant
COOPERVISION, INC.
17701 COWAN AVE.P. O. BOX
19587
IRVINE,  CA  92713
Applicant Contact DAVID W KRAPF
Correspondent
COOPERVISION, INC.
17701 COWAN AVE.P. O. BOX
19587
IRVINE,  CA  92713
Correspondent Contact DAVID W KRAPF
Regulation Number886.4150
Classification Product Code
HQE  
Date Received05/13/1987
Decision Date 06/11/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-