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 For Gastro-Urology Use
510(k) Number K854669
Device Name S.L.T. LASER DELIVERY SYSTEM FOR YAG LASER
Applicant
Surgical Laser Technologies, Inc.
250 E 5th St. Suite 1500
Columbia Plz. Bldg.
Cincinnati,  OH  45202
Applicant Contact L STUDER
Correspondent
Surgical Laser Technologies, Inc.
250 E 5th St. Suite 1500
Columbia Plz. Bldg.
Cincinnati,  OH  45202
Correspondent Contact L STUDER
Regulation Number878.4810
Classification Product Code
LNK  
Date Received11/21/1985
Decision Date 02/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-