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 Laser, Neurosurgical
510(k) Number K853580
Device Name MEDILAS 2
Applicant
Endo Lase, Inc.
Attn: Jonathan S. Kahan
815 Connecticut Ave.
Washington,  DC  20006
Applicant Contact JONATHAN S KAHAN
Correspondent
Endo Lase, Inc.
Attn: Jonathan S. Kahan
815 Connecticut Ave.
Washington,  DC  20006
Correspondent Contact JONATHAN S KAHAN
Classification Product Code
LKW  
Date Received08/26/1985
Decision Date 02/13/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-