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 K093007
Device Name ENTELLUS MEDICAL BALLOON DEVICE
Applicant
Entellus Medical, Inc.
18555 37TH AVENUE NORTH
PLYMOUTH,  MN  55446
Applicant Contact Sew-Wah Tay
Correspondent
Entellus Medical, Inc.
18555 37TH AVENUE NORTH
PLYMOUTH,  MN  55446
Correspondent Contact Sew-Wah Tay
Regulation Number874.4420
Classification Product Code
LRC  
Date Received09/28/2009
Decision Date 02/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-