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, Ent Microsurgical Carbon-Dioxide
510(k) Number K854471
Device Name PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T
Applicant
Minnesota Laser Corp.
6470 Riverview Ter. NE
Minneapolis,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Minnesota Laser Corp.
6470 Riverview Ter. NE
Minneapolis,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number874.4500
Classification Product Code
EWG  
Date Received11/06/1985
Decision Date 02/13/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-