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 K010872
Device Name ML BLADE, MODEL ML7030
Applicant
MED-LOGICS, INC.
27881 LA PAZ #G316
LAGUNA NIGUEL,,  CA  92677
Applicant Contact GARY MOCNIK
Correspondent
MED-LOGICS, INC.
27881 LA PAZ #G316
LAGUNA NIGUEL,,  CA  92677
Correspondent Contact GARY MOCNIK
Regulation Number886.4370
Classification Product Code
HNO  
Date Received03/23/2001
Decision Date 06/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-