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 Unit, Phacofragmentation
510(k) Number K862064
Device Name ENTRAVISION EP-500 I/A ECCO PACK
Applicant
ENTRAVISION, INC.
641 NUWAY CIRCLE
P.O. BOX 1738
LENOIR,  NC  28645
Applicant Contact NEWTON, R.N.
Correspondent
ENTRAVISION, INC.
641 NUWAY CIRCLE
P.O. BOX 1738
LENOIR,  NC  28645
Correspondent Contact NEWTON, R.N.
Regulation Number886.4670
Classification Product Code
HQC  
Date Received05/30/1986
Decision Date 06/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-