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 keratome, battery-powered
510(k) Number K984537
Device Name KERATOME SYSTEM, MODEL K3000
Applicant
INSIGHT TECHNOLOGIES INSTRUMENTS, LLC.
264 QUARRY RD.
MILFORD,  CT  06460
Applicant Contact CHARLES VASSALLO
Correspondent
INSIGHT TECHNOLOGIES INSTRUMENTS, LLC.
264 QUARRY RD.
MILFORD,  CT  06460
Correspondent Contact CHARLES VASSALLO
Regulation Number886.4370
Classification Product Code
HMY  
Date Received12/21/1998
Decision Date 05/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-