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 Keratoscope, Ac-Powered
510(k) Number K964290
Device Name EYECHEK
Applicant
Reichert Ophthalmic Instruments, Div. Leica, Inc.
3374 Walden Ave.
Depew,  NY  14043
Applicant Contact FRANK J DREXELIUS
Correspondent
Reichert Ophthalmic Instruments, Div. Leica, Inc.
3374 Walden Ave.
Depew,  NY  14043
Correspondent Contact FRANK J DREXELIUS
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received10/28/1996
Decision Date 01/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-