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 K903912
Device Name KERATOME
Applicant
Micro Precision Instrument Co.
4354 N. 82nd St.
Suite 133
Scottsdale,  AR  85251
Applicant Contact RUSSELL KOEPNICK
Correspondent
Micro Precision Instrument Co.
4354 N. 82nd St.
Suite 133
Scottsdale,  AR  85251
Correspondent Contact RUSSELL KOEPNICK
Regulation Number886.4370
Classification Product Code
HNO  
Date Received08/24/1990
Decision Date 10/17/1990
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
-
-