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 hook, ophthalmic
510(k) Number K864292
Device Name DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY
Applicant
EYE-KO, INC.
P.O. BOX 1632
WEST CHESTER,  PA  19380
Applicant Contact GREGORY L BEINECKE
Correspondent
EYE-KO, INC.
P.O. BOX 1632
WEST CHESTER,  PA  19380
Correspondent Contact GREGORY L BEINECKE
Regulation Number886.4350
Classification Product Code
HNQ  
Date Received10/31/1986
Decision Date 12/29/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-