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, Ac-Powered
510(k) Number K974598
Device Name MICROKERATOME OR THE MATE
Applicant
Howard Instruments, Inc.
4749 Appletree Ln.
Tuscaloosa,  AL  35405 -5747
Applicant Contact JACK HOWARD
Correspondent
Howard Instruments, Inc.
4749 Appletree Ln.
Tuscaloosa,  AL  35405 -5747
Correspondent Contact JACK HOWARD
Regulation Number886.4370
Classification Product Code
HNO  
Date Received12/09/1997
Decision Date 04/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-