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 Instrument, Catheter, Punch
510(k) Number K911104
Device Name PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1
Applicant
HGM MEDICAL LASER SYSTEMS, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Applicant Contact DENNIS REIGLE
Correspondent
HGM MEDICAL LASER SYSTEMS, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Correspondent Contact DENNIS REIGLE
Regulation Number876.5090
Classification Product Code
FEX  
Date Received03/13/1991
Decision Date 06/11/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-