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, ophthalmic
510(k) Number K852464
Device Name HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C.
Applicant
HCG, INC.
1828 SOUTH 3850 WEST
SALT LAKE CITY,  UT  84104
Applicant Contact JEROME STENEHJEM
Correspondent
HCG, INC.
1828 SOUTH 3850 WEST
SALT LAKE CITY,  UT  84104
Correspondent Contact JEROME STENEHJEM
Regulation Number886.4390
Classification Product Code
HQF  
Date Received06/10/1985
Decision Date 07/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-