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 K020079
Device Name BLADEWORKS MICROKERATOME BLADE, MODEL 7061
Applicant
Blade Works, Inc.
1816 Towhee St.
San Marcos,  CA  92069
Applicant Contact MARK MOYER
Correspondent
Blade Works, Inc.
1816 Towhee St.
San Marcos,  CA  92069
Correspondent Contact MARK MOYER
Regulation Number886.4370
Classification Product Code
HNO  
Date Received01/10/2002
Decision Date 04/19/2002
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
-
-