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 K932296
Device Name JR -- OPHTHALMIC ARGON LASER
Applicant
Carson Laserworks
P.O. Box 406
Winchester,  IN  47394
Applicant Contact RICHARD SWANSON
Correspondent
Carson Laserworks
P.O. Box 406
Winchester,  IN  47394
Correspondent Contact RICHARD SWANSON
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received05/11/1993
Decision Date 11/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-