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 K001806
Device Name REFRACTIVE SURGERY BLADES
Applicant
MILLENNIUM BIOMEDICAL, INC.
360 EAST BONITA AVE.
POMONA,  CA  91767
Applicant Contact JERRY KAENI
Correspondent
MILLENNIUM BIOMEDICAL, INC.
360 EAST BONITA AVE.
POMONA,  CA  91767
Correspondent Contact JERRY KAENI
Regulation Number886.4370
Classification Product Code
HNO  
Date Received06/15/2000
Decision Date 09/12/2000
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
-
-