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 K945382
Device Name TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER
Applicant
Expertech Assoc., Inc.
100 Main St.
Suite 120
Concord,  MA  01742
Applicant Contact DAVID M LINK
Correspondent
Expertech Assoc., Inc.
100 Main St.
Suite 120
Concord,  MA  01742
Correspondent Contact DAVID M LINK
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received11/02/1994
Decision Date 01/31/1995
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
-
-