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, Ent Manual Surgical
510(k) Number K133563
Device Name PATHASSIST LIGHT SEEKER
Applicant
Entellus Medical, Inc.
3600 Holly Lane North, Suite 40
Plymouth,  MN  55447
Applicant Contact GARRETT P AHLBORG
Correspondent
Entellus Medical, Inc.
3600 Holly Lane North, Suite 40
Plymouth,  MN  55447
Correspondent Contact GARRETT P AHLBORG
Regulation Number874.4420
Classification Product Code
LRC  
Date Received11/20/2013
Decision Date 12/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-