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 Powered Laser Surgical Instrument
510(k) Number K993834
Device Name SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C
Applicant
Cardiofocus, Inc.
987 University Ave.
Suite 14
Los Gatos,  CA  95032
Applicant Contact WILLIAM A KNAPE
Correspondent
Cardiofocus, Inc.
987 University Ave.
Suite 14
Los Gatos,  CA  95032
Correspondent Contact WILLIAM A KNAPE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/12/1999
Decision Date 02/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-